News

Parental Refusal of Neonatal Therapy a Growing Problem

07/30/2020

Parents who refuse one indicated neonatal preventive therapy often refuse others even when the reasons are different, according to an update at the Pediatric Hospital Medicine 2020 Virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance. "Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up," reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University. Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given. "There is a glaring gap in the way the [California] law was written," said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws. Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K. Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome. "This is a huge piece of the puzzle for counseling," Nguyen said. "The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death." Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Nguyen. Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Nguyen reported. "We do know confidently that oral vitamin K does often result in poor adherence," she said.

Small NY Study: Mother-Baby Transmission of COVID-19 Not Seen

07/30/2020

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital. "It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants," concluded Jeffrey Perlman, MB ChB, and colleagues. But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2. "Much more needs to be known," Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said. The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 "almost exclusively" reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic. Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and "have exhibited an unremarkable clinical course," the authors reported. The other 29 term babies were cared for in their mothers' rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery.

Stillbirth Incidence Increases During COVID-19 Pandemic

07/30/2020

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital. "The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden," Asma Khalil, MD, of St George's University of London and coauthors reported in JAMA. To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George's University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births. Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01). None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks' gestation, births after 34 weeks' gestation, neonatal unit admission, or cesarean delivery.

Cerclage in Twin Pregnancies Reduces Perinatal Mortality

07/30/2020

Among women with twin pregnancies and asymptomatic cervical dilation before 24 weeks, cerclage reduced perinatal mortality and preterm birth, according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention. The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage. "We've already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success," senior author Vincenzo Berghella, MD, said in a news release. "These results have the potential to change practice and help many more women have healthy twin babies," said Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia. More research is needed to establish a standardized approach, but the trial should "open physicians' perspectives to think about how, in selected cases and with the proper approach, cerclage can work well," said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore. Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. "If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea," Turan said in an interview. In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, "Do the stitch," he said. "But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome." The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it "unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study," the researchers said. Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.

OB-GYNs Struggle to Keep Pace With Changing COVID Knowledge

07/30/2020

In early April, Maura Quinlan, MD, was working nights on the Labor and Delivery unit at Northwestern Medicine Prentice Women's Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for the SARS-CoV-2 virus. Women in labor wore N95 masks, but only while pushing — and practitioners didn't always don proper protection in time. Babies came and families rejoiced. But Quinlan looks back on those weeks with a degree of horror. "We were laboring a bunch of patients that probably had COVID," she says, and they were doing so without proper protection. She's probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk. Quinlan already knew she and her fellow Ob/Gyns had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus. Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their healthcare workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.

Living Near Gas Flaring Sites May Increase Risks

07/30/2020

Women living near oil and gas production sites where natural gas is flared may be at a higher risk of giving birth preterm, a team of California researchers reported on Wednesday. Analysis of more than 23,000 birth records from 2012 through 2015 reveals a 50% higher chance of pre-term birth for women living within three miles (5 km) of Texas' Eagle Ford shale basin than for women who lived farther away, according to the study. "Our study finds that living near flaring is harmful to pregnant women and babies," said co-author Jill Johnston, an environmental health scientist at the University of Southern California. The research, published in the journal Environmental Health Perspectives, adds to evidence linking pollution with poorer pregnancy outcomes. Another study in June found a correlation between air pollution or higher outdoor temperatures and increased chances of having a preterm or stillborn baby. Those findings, in the Journal of the American Medical Association, resulted from analyzing 70 studies covering 32 million births. It also found that black women were disproportionately at risk. In the new study, by scientists at USC and UCLA, the association between preterm births and flaring proximity was seen only among Hispanic and Latina women, who made up 55% of the study population. No effect was seen among non-Hispanic White women, who comprised 37% of the total. Preterm babies are at higher risk of respiratory and cardiovascular illness, as well as developmental delays. The team said it was the first to look at birth outcomes in relation to oil and flaring, which has seen a sharp increase in southern Texas' Eagle Ford and other shale hubs. Flares can release chemicals such as benzene, carbon monoxide and nitrogen oxides, along with fine particulate matter, heavy metals and black carbon.

Too Many Children Receive Opioids/Steroids for Pneumonia and Sinusitis

07/30/2020

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina. Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics. "Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription," wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. "These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines." To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included. The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis. Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001). Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001). In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis. "I was disappointed to read of these results, although not necessarily surprised," Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said. The data suggest that improved prescribing practices may be needed, "especially in the ED," wrote Dr. Phang and colleagues. "Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients." Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. "Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control," they wrote.

Neotech Earns B Corp Certification

07/29/2020

Neotech announced its newly earned B Corp certification, furthering a commitment to using business as a force for good. “Since its inception, Neotech has always strived to create a lasting impact and do the right thing. Becoming certified as a B Corp is a natural step for Neotech,” said Henry Heyman, Neotech Consultant. “It’s a way to solidify many of the amazing initiatives and choices Neotech has already made.” Certifying as a B Corporation goes beyond product or service level certification. B Corp Certification is the only certification that measures a company’s entire social and environmental performance. The B Impact Assessment evaluates how a company’s operations and business model impacts its workers, community, environment, and customers. From supply chain and input materials to charitable giving and employee benefits, B Corp Certification assures that Neotech is meeting the highest verified standards of social and environmental performance. “We are extremely happy that Neotech Products has joined our community of Certified B Corporations,” said Lindsey Wilson, B Lab Senior Associate, Business Development. “Neotech’s existing culture and values align perfectly with the global B Corp movement to redefine success in business to balance both profit and purpose. With their dedication to their customers, their employees, and the community, Neotech serves as an excellent example of People Using Business as a Force for Good,” Wilson continued. In conjunction with the B Corp initiative, Neotech has recently launched the Being the Difference charitable giving program. Being the Difference launched in May 2020 with three newly-formalized opportunities to individuals and organizations in need: Product Donations, Monetary Donations and Scholarship Aid. Additionally, Being the Difference encompasses our two existing Research Grant programs.

Premature Infants Go Home Earlier

07/29/2020

A retrospective study indicates that premature infants’ stays in neonatal intensive care units (NICUs) are reduced anywhere from 4.5 to 22.9 days when fed Prolacta Bioscience 100% human milk-based products as a part of an Exclusive Human Milk Diet (EHMD). Additional research suggests that infants with bronchopulmonary dysplasia (BPD), a common complication of prematurity, may benefit the most from an EHMD when it comes to shortening their hospital stays. A retrospective study published in the Journal of Perinatology found that 293 infants between gestational ages 23 and 34 weeks and birth weights between 490 and 1,700 g who received Prolacta’s fortifiers as part of an EHMD achieved full feeds at faster rates and ultimately reduced their NICU stay by 4.5 to 22.9 days, compared with infants fed their mother’s milk with a cow milk-based fortifier or a combination of mom’s milk with cow milk-based fortifier and formula. Frontiers in Pediatrics published findings from a study of more than 12,000 premature infants born at ≤ 28 weeks indicating that among the 41% who developed BPD, hospital stays were 19 days longer on average (P = .001) than those who did not develop BPD. A secondary analysis of a study that originally looked at the impact of Prolacta’s cream fortifier on growth among premature infants weighing 750 to 1,250 g showed that adding Prolacta’s human milk-based cream fortifier to an EHMD resulted in an average stay in the NICU that was 12 days shorter, from 86 days without the cream supplement to 74 days when it was used. In this study, the infants with BPD may have benefited the most from the addition of Prolacta’s cream fortifier, with 17 fewer days in the NICU, from an average of 121 to 104 days (P = .08). This updated analysis was published in Breastfeeding Medicine in 2016. A 2019 study published in Advances in Neonatal Care compared 104 infants born weighing ≤ 1,250 g who received an EHMD to a similar group of 101 infants who received cow milk-based fortifier. In this study, an EHMD was associated with decreased rates of BPD (P = .018) and sepsis (P = .06) and an average five-day reduction in length of hospital stay. “The goal of all parents with a premature infant in the NICU is to bring their baby home as soon as possible. When you add the concerns about exposure to hospital-based infections for both the parents and the baby, that desire for discharge is stronger than ever,” said Melinda Elliott, M.D., chief medical officer of Prolacta. “The clinical evidence shows an EHMD including Prolacta’s products helps to overcome the complications of prematurity, resulting in better health outcomes and shorter hospital stays in the NICU.”

Study Results Released on Screening for Newborns

07/20/2020

Masimo announced the results of a prospective study published in the International Journal of Neonatal Screening in which researchers in Marrakesh, Morocco, conducted the first Moroccan study on critical congenital heart disease (CCHD) screening for newborns using Masimo SET pulse oximetry. The authors concluded that “Our results encourage us to strengthen screening for CCHD by adding pulse oximetry to the routine newborn screening panel.” Slitine and colleagues sought to improve early detection of CCHD in Morocco by studying the feasibility of implementing CCHD screening using pulse oximetry. From March 2019 to January 2020, 8,013 asymptomatic newborns at Mother and Child Hospital (part of the Mohammed VI University Hospital of Marrakesh), who were “normal” according to neonatal examination using the current standard, were screened for CCHD in accordance with American Academy of Pediatrics (AAP) guidelines, including pre- and post-ductal oxygen saturation measurement, using Masimo Rad-97 and Radical-7 Pulse CO-Oximeters with Masimo SET pulse oximetry sensors. The researchers found that, of the 8,013 infants screened, 7,998 newborns had a negative screen (99.82%) and 15 newborns were screen positive (0.18%). Of those 15, five were later diagnosed with CCHD and five with non-critical CHD; five were false positives (three of which had other underlying conditions). Of the 7,998 infants who passed, there was one false negative, an infant who was later diagnosed, at 2 months of age, with coarctation of the aorta. The researchers noted that the screening test was “easy, simple, reliable, reproducible, acceptable, discriminating, well-accepted by parents and caregivers, and did not involve parental anxiety.” They also noted that “Pulse oximetry has a good specificity and sensitivity and thereby fulfills the criteria for screening. Additionally, most of the data in the literature suggest a favorable cost-effectiveness of this technique.” The authors concluded, “Screening for CCHD is a reliable method for the early detection of critical congenital heart disease and even non-cardiac conditions. We think that it will have positive repercussions on infant mortality and morbidity in Morocco. It is an optimal test and it adapts perfectly to our context. We hope to implement it locally and nationally, as consistent with international best practice for newborn screening, to allow for timely detection of the infants born with CCHD in Morocco.”Although the researchers at times use the term pulse oximetry generally, the specific pulse oximetry technology used in this study, as noted, was Masimo SET. To date, six other large published CCHD screening studies, as well as additional, smaller studies, have used Masimo SET. Cumulatively, the large studies represent 284,800 infants, which includes the largest CCHD study to date, of 122,738 newborns. All of these CCHD studies with Masimo SET pulse oximetry showed improved screening sensitivity with the use of Masimo SET alongside clinical assessment when compared to routine physical exam alone. With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, Masimo SET stands out as the established choice of pulse oximetry technology for clinicians and policy makers hoping to implement CCHD screening processes.

Sign Up for This Webinar on Gut Health

07/15/2020

Astarte Medical has an upcoming webinar with Dr Nicholas Embleton.
Registration and Complete Event Details: https://bit.ly/2C6EN4e
Event: Nutritional Status and Gut Health in Preterm Infants What is it, and how do we assess it?
Featured Speakers: Dr. Nicholas Embleton
Date: Wednesday, July 29, 2020
Time: 12:00 p.m. ET
Topics of discussion will include:

• A comprehensive practical approach to nutrition requires recognition of multiple interacting elements.
• Nutrition includes 1) nutrients 2) functional components 3) microbiome 4) socio, techno, behavioral aspects.
• Breastmilk is more than food.
• Nutritional status is a multidimensional and dynamic concept - what you are, what you eat, what you can do.
• Assessment of nutritional status requires a structured approac
• Gut health is a continuum rather than a binary outcome of 'healthy' or 'unhealthy.'

CDC Revises COVID-19 Risks During Pregnancy as Research Lags

07/15/2020

In late June, after three months of near silence on the topic, the Centers for Disease Control and Prevention finally weighed in on a question of critical importance to millions of American women and families: How dangerous is the coronavirus for pregnant women and new mothers? The CDC had been asserting that pregnant women don't seem to be at higher risk for severe complications from the virus. As recently as late May, a spokesperson told ProPublica, "Current evidence shows pregnant women have the same risk of severe illness from Covid-19 as adults who are not pregnant." Then, the agency abruptly changed its tone. In its first examination of data on Covid-19 in pregnancy, the CDC found that expectant mothers with the virus had a 50 percent higher chance of being admitted to intensive care and a 70 percent higher chance of being intubated than nonpregnant women in their childbearing years. Pregnant Latina and Black women were infected at significantly higher rates than White women, researchers reported. As of July 2, at least 30 expectant and new mothers with the virus had died. That news was sobering enough. But what many experts found really worrisome were the glaring gaps in data that the study exposed. The CDC acknowledged that crucial health information was missing for about three-quarters of pregnant women with the virus, including whether they had preexisting conditions or required an ICU stay or mechanical ventilation. For the vast majority of US women of reproductive age who tested positive — about 326,000 women through June 7 — there was no information about pregnancy status at all. Researchers couldn't even say how many of the hospitalized mothers-to-be — 31.5 percent of the pregnant women in the study — had been admitted because of Covid-19, versus how many were in the hospital for other reasons, such as giving birth. The flawed CDC report highlights a problem that OB-GYN providers and researchers in the U.S. have been fretting about since the pandemic began. Because emerging diseases can have catastrophic consequences for pregnant women and their babies, close monitoring of new illnesses in this vulnerable population is important. So is rapid communication with providers trying to keep their patients safe. But the US public health system's efforts to understand the impact of the coronavirus in mothers and babies have been flat-footed, scattershot and agonizingly slow.

'Time to Lay to Rest' Fears About Dolutegravir Birth Defects

07/15/2020

The longer researchers have looked for evidence of neural tube defects linked with dolutegravir treatment of HIV at the time of conception the fewer incident cases they've found. The newest data, based on 3,591 deliveries among women in Botswana infected by HIV and treated with dolutegravir at the time of conception during a little more than 5.5 years through April 2020, showed that dolutegravir use at conception linked with 7 cases of neonatal neural tube defects (NTDs), a 0.19% rate that exceeded comparator rates by about 1 in every 1,000 deliveries, far below the 0.94% rate initially found and that raised a red flag 2 years ago. "The prevalence of NTDs among infants born to women on dolutegravir at conception may be stabilizing at approximately 2 per 1,000," said Rebecca Zash, MD, during the virtual meeting of the International AIDS conference. "This small absolute risk for neural tube defects is far outweighed by the potential benefits from dolutegravir" for better tolerability than alternative drugs and fewer drug–drug interactions. "This should allow for broader use of dolutegravir in women," added Zash, an HIV specialist at Beth Israel Deaconess Medical Center and codirector of the Placental Scientific Working Group of the Harvard University Center for AIDS Research, both in Boston. "What this has taught us is that women are not a niche population" of people infected with HIV, but rather constitute about half of HIV patients worldwide. "Maintaining gender equity in HIV treatment requires safety data for treatments during pregnancy," she said during a press briefing. The new findings mean that it's "time to lay to rest" concerns about neural tube defects in infants born to women treated with dolutegravir, "given the incredible benefits of dolutegravir," commented Monica Gandhi, MD, professor of medicine and associate chief of the division of HIV, infectious disease, and global medicine at the University of California, San Francisco. Another benefit from removing any caveats about use of dolutegravir in women who could become pregnant is that it would simplify treatment recommendations and make dolutegravir the unqualified first-line agent for treating HIV infection, Dr. Gandhi said during the briefing. "It's super reassuring to have these data, as the incidence of NTDs goes down and down," she added. Following the alarm raised by initial findings from the Tsepamo study in 2018, Zash and associates first updated their data through March 2019, when they reported a revised cumulative NTD incidence rate of 0.3%. The Tsepamo study began by following the pregnancy outcomes of women at eight Botswana sites during August 2014–July 2018, representing 45% of the country's deliveries. This expanded to 18 sites and 72% of deliveries during July-–September 2018, and then starting in September 2019 the scope slightly reduced to 16 Botswana sites with 70% of the nation's deliveries. Folate supplementation to women who might conceive is vital, but remains spotty in Botswana. "Folate supplementation is a no-brainer, but has had really slow adoption in many countries," Zash said. "Folate supplementation, especially in food so that everyone gets it, will reduce NTDs by half." The two most recent cases of infants born with a NTD to mothers who had been on dolutegravir at conception occurred in mothers who had received no folate supplementation, Zash reported.

Neonatal SARS-CoV-2 May Present With Hypoxemia Without Respiratory Distress

07/15/2020

Neonatal SARS-CoV-2 infection may present in the first days of life with clinically significant hypoxemia in a newborn that doesn't have overt signs of respiratory distress or require oxygen therapy, one case report suggests. "In mild disease, there may be non-specific signs such as poor feeding that alert the care-providers, before signs of respiratory distress are noted," said Dr Shaili Amatya, an assistant professor in neonatal-perinatal medicine at Penn State Health Children's Hospital in Hershey, Pennsylvania, who wasn't involved in the study. "The physiological mechanisms underlying the effects in infants versus older children are unknown," Amatya said by email. "The immature immune system of children may respond to SARS-CoV-2 differentially in various age groups." The case, highlighted in Pediatrics, involved a full-term male newborn with an uncomplicated vaginal delivery with Apgar scores of 9 and 10 at 1 minute and 5 minutes, respectively. On the second day after delivery, the mother developed a fever and had a nasopharyngeal swab that was positive for SARS-CoV-2; the infant was subsequently swabbed, and also positive. Mother and baby were transferred to an airborne isolation room. After 48 hours, the newborn developed poor sucking and perioral cyanosis without signs of respiratory distress. The baby's respiratory rate was 15 to 20 per minute, heart rate was 120 beats per minute, and blood pressure was normal. Cardiac abnormalities were ruled out by echocardiogram, and PCR on the nasopharyngeal specimen ruled out other respiratory viruses. The baby was moved to the NICU, where he was put on 30% inspired oxygen via high flow nasal cannula. Lung ultrasound at this point didn't show consistent abnormalities, and chest radiograph showed mild bilateral ground glass opacities. After 36 hours, no major abnormalities were found on CT scan. Fifty hours after NICU admission, the infant improved enough to have respiratory support discontinued. He was fed maternal expressed milk via nasogastric tube for 48 hours, then was able to bottle feed. At day 18, the baby was discharged. On days 15 and 21, his qualitative PCR for SARS-CoV-2 remained positive, the researchers note. This suggests that newborns could be a source of horizontal transmission, the study team concludes in Pediatrics.

 

Fortifiers Helped Infants Grow

07/14/2020

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced the results of an independent, multicenter study of 394 extremely premature infants that demonstrated the benefits of an early versus late fortification feeding protocol. According to this study, the use of Prolacta’s fortifiers in the first days of life helped premature infants achieve better growth and is associated with significantly less bronchopulmonary dysplasia (BPD)/chronic lung disease of prematurity (CLD), all without compromising safety. The study was led by author Robert K. Huston, MD, and published in the Journal of Neonatal-Perinatal Medicine. Lung health is an important short- and long-term outcome for preterm infants. However, because the lungs are among the last organs to mature in the womb, lung dysfunction such as BPD/CLD is common in preterm infants. Neonatal nutrition is a critical consideration in addressing lung health; however, many neonatal intensive care units (NICUs) delay adding a fortifier to extremely premature infants’ feeds due to the risk of complications associated with cow milk-based fortifiers. This study showed that adding Prolacta’s human milk-based fortifiers in the first days of life resulted in greater growth velocities for weight and head circumference and a 15% reduction in BPD/CLD (P = 0.008), compared with infants who received late fortification. These benefits were seen without an increase in complications. Infants who received early fortification in the study did not show significant increases in necrotizing enterocolitis (NEC) or surgical NEC, life-threatening complications that limit the use of early fortification with cow milk-based fortifiers. The Huston Early Fortification Study investigators compared the outcomes of infants born weighing 500 to 1,250 g whose feedings included mother’s own milk, donor milk when needed, and Prolacta’s human milk-based fortifiers at less than 60 mL/kg/day (early fortification) or greater than 60 mL/kg/day (late fortification). “The Huston Early Fortification Study provides further data to support the practice of early fortification in extremely premature infants,” said Melinda Elliott, M.D., chief medical officer of Prolacta Bioscience. “Not only was early fortification proven safe, it also enhanced growth and reduced the incidence of BPD.”

Babies Born With Virus, Parents Don’t Have It

06/30/2020

Mexican health authorities are trying to understand how a set of newborn triplets became infected with the novel coronavirus even though neither one of their parents tested positive for the virus. Health authorities called the case "unheard of." The triplets, a girl and two boys, were tested four hours after being born about six weeks early last week in the central state San Luis Potosi, health authorities said. State Health Secretary Dr. Monica Liliana Rangel Martinez told reporters that it is protocol to test all premature babies for the virus. Initially, health authorities said the mother was believed to be an asymptomatic carrier of the virus. But her tests later showed that neither she nor the father were infected. "The parents' results are negative, which catches our attention," Martinez said. "We specifically requested since yesterday ... that a group of experts investigates the case." Two of the babies born on June 17 are in good health and show no symptoms of COVID-19, doctors treating the triplets said, while the third has pneumonia but is in stable condition. Rangel said the triplets will remain hospitalized and under observation. Mexico has reported more than 191,000 coronavirus cases and 23,377 deaths, according to the global tracking dashboard being kept by Johns Hopkins University.

Women, Babies at Risk as COVID-19 Disrupts Health Services

06/30/2020

Millions of women and children in poor countries are at risk because the COVID-19 pandemic is disrupting health services they rely on, from neonatal and maternity care to immunisations and contraception, a World Bank global health expert has warned. Monique Vledder, head of secretariat at the bank's Global Financing Facility (GFF), told Reuters in an interview the agency was gravely worried about the numbers of children missing vaccinations, women giving birth without medical help and interrupted supplies of life-saving medicines like antibiotics. "We're very concerned about what's happening - particularly in sub-Saharan Africa," Vledder said as she unveiled the results of a GFF survey, one of the first seeking to assess the impact of COVID-19 on women's and children's health. "Many of the countries we work in are fragile and so, by definition, already have very challenging situations when it comes to health service delivery. This is making things worse." From late March, the GFF has conducted monthly surveys with local staff in 36 countries to monitor the impact of COVID-19 on essential health services for women, children and adolescents. Sharing the survey findings, GFF said that of countries reporting, 87% said the pandemic, fears about infection or lockdown measures designed to curb the spread of the coronavirus, had led to disruptions to health workforces. More than three-quarters of countries also reported disruptions in supplies of key medicines for mothers and babies, such as antibiotics to treat infections and oxytocin, a drug for preventing excessive bleeding after childbirth. The number of GFF countries reporting service disruptions nearly doubled from 10 in April to 19 in June, and the number reporting fewer people seeking essential health services jumped to 22 in June from five in April. GFF found that in Liberia, for example, fears about COVID-19 were preventing parents from taking their children to health clinics. In Ghana, some pregnant and lactating mothers were opting to postpone antenatal services and routine immunisations for fear of contracting the pandemic disease.

New Data on Hypertension

06/30/2020

Using the new clinical definitions of hypertension, pregnant women with even modest elevations in blood pressure (BP) are at increased risk for preeclampsia, according to results from a large retrospective cohort study. In a 2017 guideline, the American College of Cardiology and American Heart Association changed clinical definitions of hypertension in adults. People previously deemed to have prehypertension were classed as having elevated blood pressure (systolic BP 120-129 mm Hg and diastolic BP >80 mm Hg) or stage 1 hypertension (systolic 130-139 mm Hg or diastolic 80-89 mm Hg). And while hypertension as earlier defined (at or above systolic 140 mm Hg or at or above diastolic 90 mm Hg; now called stage 2 hypertension) has been long associated with adverse maternal and fetal effects, it was unclear whether lesser elevations in blood pressure also are linked to the same. For their research published in Obstetrics & Gynecology, Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby and had two or more prenatal appointments before week 20 of pregnancy. The women in the study were seen at the same institution over a 3-year period ending in 2018. Three-quarters of the cohort had normal blood pressure, while 14% had elevated blood pressure and 5% had stage 1 hypertension before 20 weeks. Another 6% of the cohort had stage 2 hypertension. The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks' gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did with 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Both term and preterm preeclampsia were factors in women with stage 1 and stage 2 hypertension, but preterm preeclampsia was associated with a higher risk. Although black race was associated with a higher risk of preeclampsia, the pattern of increasing risk with higher blood pressure category was similar in both black and white women. Researchers also looked at gestational diabetes, severe maternal morbidity, neonatal morbidity, and placental abruption as secondary outcomes. They found the risk of gestational diabetes increased in a stepwise fashion as blood pressure increased, compared with normotensive women. Higher risk of severe maternal and neonatal morbidities was seen only in women with stage 2 hypertension. Placental abruption was rare in this cohort and the odds were not increased in any group. The findings "highlight the importance of early pregnancy BP elevations, which may reflect prepregnancy BP status," and suggest that the new guidelines "can identify women early in pregnancy who may benefit from increased surveillance," Dr. Sutton and colleagues wrote.

Cesarean Delivery Tied to Worse Outcomes in Women With COVID-19

06/30/2020

Cesarean delivery was associated with severe maternal outcomes and clinical deterioration compared to vaginal delivery among women infected with COVID-19 in Spain. "We were really surprised by the high rate of cesarean section in (COVID-19 patients) in China," Dr David Baud of Lausanne University Hospital in Switzerland, said. "We were not so surprised to discover (in our own study) that vaginal delivery is safer in (such) patients." Baud and colleagues studied data on women in Spain with SARS-CoV-2 and singleton pregnancies between March 12 and April 6, 2020, and who delivered within the next 14 days. As reported in JAMA, among the 82 participants, four presented with severe COVID-19 symptoms, including one with concomitant preeclampsia. All four underwent cesarean delivery and required ICU admission. Seventy-eight women presented with no or mild COVID-19, including 11 who required oxygen supplementation. Forty-one (53%) delivered vaginally and 37 (47%) by cesarean delivery for obstetrical indications and eight for COVID-19 symptoms without other obstetrical indications. Compared to those delivering vaginally, women who underwent cesarean deliveries were more likely to be multiparous, obese, require oxygen at admission, and have abnormal chest x-ray findings. No severe adverse outcomes occurred in women who had a vaginal delivery. However, five (13.5%) who underwent a cesarean required ICU admission. Two (4.9%) with a vaginal delivery experienced clinical deterioration after birth vs eight (21.6%) with cesarean delivery. After adjustment for potential confounders, cesarean birth was significantly associated with clinical deterioration (adjusted odds ratio, 13.4). Eight newborns (19.5%) delivered vaginally and 11 (29.7%) born by cesarean delivery were admitted to the neonatal ICU. After adjustment, cesarean birth was significantly associated with an increased risk of NICU admission (aOR, 6.9). Three newborns delivered vaginally tested within 6 hours after birth had a positive SARS-CoV-2 RT-PCR result. However, repeat testing at 48 hours was negative. None developed COVID-19 symptoms within 10 days.

The evidence for HeRO continues to build

06/29/2020

Two more publications about HeRO are now available. Please check the company’s publications page on its website regularly for the details and links to all the papers. If you have ideas for new research topics or if you are interested in deploying HeRO in your unit, then reach out. Following their earlier work on the use of HeRO with respect to intubation and extubation, Chakraborty et. al, have published Predicting Extubation Outcomes Using Heart Rate Characteristics Index in Preterm Infants: A Cohort Study. They present predictive models that assess readiness for extubation using physiological data and HeRO. These models are freely available, hosted by MPSC.

Device Helps Neonatal Oral Intubations

06/16/2020

The SecureET Neonatal Endotracheal Tube Securement Device from Westmed (westmedinc.com) is the latest design available for neonatal oral intubations. The SecureET Endotracheal Tube holder features hydrocolloid material for skin contact and helps prevent accidental extubation by providing a secure method of stabilization. SecureET enables fast and easy application to secure endotracheal tubes sizes 2.5, 3.0, 3.5, and 4.0 mm. Each device is color coded for the size tube. SecureET facilitates placement options for the tube location in the oral cavity and may be moved to prevent palate grooving. SecureET allows for tube depth adjustment without disturbing the skin contacting hydrocolloid base. In addition, SecureET is the only neonatal ET Tube securement device with an optional head bonnet for superior security.

Doctors Can Help Parents Cope in the NICU

06/15/2020

Parenting a newborn can be a tough journey, and bonding with a new baby in a neonatal intensive-care unit (NICU) is even more difficult given the medical uncertainties, fear and complex emotions, according to a group of pediatricians. But healthcare providers can help parents cope, the group writes in Pediatrics, by communicating three messages: You are a parent, you are not a bad parent, you are a good parent. "When your child is sick, it is not rare for parents to wonder what they could have done to prevent the illness," said Dr Annie Janvier of Sainte-Justine University Medical Centre in Montreal, Canada, one of the authors of the report. In a NICU, the feelings are even more intense, she added. Mothers may feel their baby is sick because of their body, and fathers may feel helpless about what to do.

"Finding your parental roles in the NICU and feeling like a parent can take some time," she told Reuters Health by email. "Sometimes you can also feel ambivalence attaching because you are scared your baby will die." Janvier and colleagues at several hospitals in the US and Canada write about the stress that parents face in the NICU, as well as several strategies that doctors can take to help parents. They write from their experience as healthcare providers and also as parents or grandparents who have had children in the NICU. "Clinicians can harm parents inadvertently, for example, when they assume that 'mothers love to take their kid in their arms,' as some mothers may be frightened at first when their baby is unstable," Janvier said. Doctors and NICU providers can help parents by supporting "good parent" beliefs, which can guide parenting and decision-making and reduce anxiety, depression, prolonged grief and posttraumatic stress disorder, they write. The first message to communicate is "You are a parent," the authors write, because parents of infants in the NICU need to feel like "real" parents. They may feel conflicted about whether to invest emotionally in a baby who could die, looks fragile or could have future health problems.

When doctors use medical language such as "nonviable" or "congenital anomalies incompatible with life," these feelings are exacerbated, the authors write. Separation after birth, and breathing tubes and wires can interfere with bonding.

Possible Vertical Transmission of Novel Coronavirus

06/15/2020

Clinicians in Italy report two cases of possible vertical transmission of SARS-CoV-2, the virus responsible for COVID-19, from the mother to the baby in utero. "To our knowledge, ours is the first report of cases of positive polymerase chain reaction (PCR) for SARS-CoV-2 in mother, neonate and placental tissues," Dr Luisa Patane and colleagues of ASST Papa Giovanni XXIII in Bergamo write in the American Journal of Obstetrics and Gynecology - Maternal Fetal Medicine. Vertical transmission of SARS-CoV-2 remains controversial and studies on placental correlations are limited. Patane and colleagues report that between March 5 and April 21, two of 22 babies born to women with COVID-19 were PCR positive for SARS-CoV-2 in nasopharyngeal (NP) swab samples. The first baby, a boy, was born vaginally after spontaneous labor at around 37 weeks' gestation to a mother who was experiencing fever and cough and had a positive SARS-CoV-2 NP swab. The mother wore a surgical mask during labor and delivery, skin to skin contact was not allowed, but rooming-in and breastfeeding with mask were allowed. The baby had positive NP swabs immediately at birth, after 24 hours, and after seven days. He remained asymptomatic, except for mild initial feeding difficulties, and was discharged from the hospital at 10 days of life. The second baby, a girl, was delivered by cesarean section at 35 weeks' gestation to a mother who had also had fever and cough and positive COVID-19 NP swab. The baby was immediately separated from the mother at birth and admitted to the neonatal intensive-care unit. The baby had a negative NP swab at birth and a positive NP swab at day seven, with no contact between mother and neonate during that period. No neonatal complications were observed, only some feeding difficulties were reported in the first days of life; she was discharged at 20 days life 20. In both cases, SARS-CoV-2 RNA was found in placental tissue. The presence of SARS-CoV-2 RNA in the syncytiothrophoblast - the epithelial covering of the embryonic placental villi, which invades the wall of the uterus to establish nutrient circulation between the embryo and the mother - signifies presence of the virus on the fetal side, the clinicians point out. "This is the first study describing SARS-CoV-2 RNA on the fetal side of the placenta in two cases of mothers infected with COVID-19 and with neonates also positive for the virus at birth," they note.

Breastmilk of Mother With COVID-19 Tests Positive for SARS-CoV-2

06/15/2020

Breastmilk samples from a nursing mother infected with SARS-CoV-2 has tested positive for the virus, researchers report. "The breastmilk of SARS-CoV-2-infected women may contain the virus. However, we described a single case and currently do not know how frequent this is, whether the virus in milk is infectious and whether it may indeed be transmitted to the newborn by breastfeeding," Dr Jan Muench of the Institute of Molecular Virology at Ulm University Medical Center in Germany said by email. Small studies have not found evidence of SARS-CoV-2 shedding into breastmilk, Muench and colleagues write. They tested milk from two nursing mothers with SARS-CoV-2 using RT-qPCR. Mother 1 developed symptoms of COVID-19 after delivery and tested positive for SARS-CoV-2. The newborn tested positive for SARS-CoV-2 and had respiratory symptoms. Both mother and infant recovered. Four breastmilk samples were taken from Mother 1 and all were negative for the virus. Mother 2 and Newborn 2 were put in the same room as Mother 1 and Newborn 1. They were discharged on day 4. Mother 2 developed mild COVID-19 symptoms, and both she and her baby tested positive for SARS-CoV-2. The baby was readmitted to the hospital due to icterus and breathing problems. On days 10 to 13 after initial hospital admission, breastmilk samples from Mother 2 tested positive for the virus. Two subsequent samples were negative. The authors note that Mother 2 had been wearing a surgical mask after she developed COVID-19 symptoms and followed safety precautions while feeding and handling the baby. "We plan to recruit more infected mothers to 1) determine how often SARS-CoV-2 is present in milk and at which quantities; 2) to figure out whether the virus in milk is indeed infectious; 3) to check whether the virus in milk could be inactivated by pasteurization and/or storage 4) to check for anti-SARS-antibodies in milk and their neutralization efficiency; and 5) finally proof whether the virus may be transmitted via breast milk to the newborn," Muench said.

Placental Injury Reported in Women With COVID-19

06/15/2020

Maternal vascular malperfusion and intervillous thrombi were more common in the placentas of women infected with SARS-CoV-2, compared with historic controls, report researchers who conducted the first-of-its-kind case series in the English literature. Nevertheless, the neonates in the report appear to be healthy so far and all tested negative for the virus. Although the series examining placentas from 16 women is small, it carries a larger implication – that increased antenatal surveillance for pregnant women infected with SARS-CoV-2 may be indicated, the researchers noted. Furthermore, the results could align with other reports of coagulation and vascular abnormalities among people with COVID-19. "I would say that our findings fit into that larger picture of vascular injury. This is developing, and there are some significant ways that these feeder vessels to the placenta are different, but if this is the emerging paradigm, our findings can fit into it," Jeffrey A. Goldstein, MD, PhD, assistant professor of pathology at Northwestern University, Chicago, said in an interview. The research was published in the American Journal of Clinical Pathology. Prior case series reported in Wuhan, China, do not currently suggest that pregnant women are more likely to experience severe COVID-19, in contrast to observations during severe acute respiratory syndrome and Middle East respiratory syndrome outbreaks. "However," the researchers noted, "adverse perinatal outcomes have been reported, including increased risks of miscarriage, preeclampsia, preterm birth, and stillbirth." To learn more, Dr Goldstein, lead author Elisheva D. Shanes, MD, and colleagues examined the histology of placentas from women with COVID-19 giving birth between March 18 and May 5, 2020. They compared these placentas with over 17,000 historic controls and 215 women who had their placentas evaluated as part of a melanoma history study.

Study Highlights Growth of Babies

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced the results of a long-term pilot study showing that premature infants fed an exclusive human milk diet (EHMD) including Prolacta’s fortifiers reached the same healthy growth and developmental milestones by age 2 that are seen in full-term infants. The study was published in the May 2020 issue of Breastfeeding Medicine. Authored by Erynn M. Bergner, M.D., and colleagues, the new study is the first to concurrently evaluate long-term neurodevelopmental, growth, and body composition outcomes of preterm infants in the neonatal intensive care unit (NICU). Researchers found: Preterm infants receiving Prolacta’s 100% human milk-based fortifiers returned to birth z-scores for weight, length, and head circumference by age 2; similar percentage of body fat and lean mass in preterm infants at age 2, compared to matched term controls, with adequate bone mineralization; not a single case of severe cognitive developmental delay using a Bayley Scales of Infant and Toddler Development III (BSID-III) cutoff score of <70 at 18 to 22 months corrected age (CA). “As we continue to optimize nutritional practices in the NICU and investigate an entirely human milk-based approach for the diets of preterm infants, it is important to follow the potential impact of these changes on health and development long-term,” Dr Bergner wrote. Bergner et al evaluated the post-discharge growth, body composition, and neurodevelopmental outcomes of a cohort of infants ≤1,250 g birth weight who received Prolacta’s fortifiers as part of an EHMD in the NICU. The infants were studied prospectively at two outpatient visits: 12 to 15 and 18 to 22 months (CA). Dual-energy X-ray absorptiometry and BSID-III were performed at 18 to 22 months (CA). “The Bergner study demonstrates what we’ve long suspected – that the numerous health benefits we see in the NICU with Prolacta products as part of an Exclusive Human Milk Diet translate into longer-term neurodevelopmental and metabolic health outcomes,” said Melinda Elliott, chief medical officer for Prolacta Bioscience.

Probiotics Receive Conditional Recommendation

Babies born preterm—before 37 weeks of gestation—account for approximately 15 million births worldwide each year, according to the World Health Organization. This extremely vulnerable population of infants are at risk for multiple complications, including susceptibility to NEC, a serious disease that causes tissue damage to the intestines resulting from bacteria invading the intestinal walls. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) working group on probiotics and prebiotics conducted an extensive review of the clinical evidence surrounding probiotic use in the NICU. The working group published guidelines conditionally recommending specific strains of probiotics, including the combination of B.infantis (BB-02), B.lactis (BB-12), and S.thermophilus (TH-4), as it might reduce NEC stage 2 or 3 in preterm infants (low certainty of evidence), provided all safety conditions are met. The safety conditions include use of strains without transferable antibiotic resistance genes, correct strain identity and lack of product contamination that were manufactured in accordance with good manufacturing practices (GMPs). The authors note that only a limited number of strains have shown clinical effectiveness in this patient population. The guidelines also highlight the importance of assessing the safety in overall product manufacturing. This includes understanding a probiotic’s potency, stability and purity. Preterm infants are deprived of adequate time in utero for growth of critical organs, including the digestive system where 70% of the immune system resides. In addition to an underdeveloped digestive system, preterm infants can experience imbalances in gut bacteria. The use of probiotics in this population may reduce the incidence of NEC. Currently ~20% of NICUs in the United States use probiotics when treating and caring for preterm infants. “A high-quality probiotic that has been studied in preterm infants would equip clinicians in the NICU with the ability to mitigate some of the risks associated with preterm births, including necrotizing enterocolitis, that can affect these babies,” said Dr Karyn Wulf, MD, MPH, Pediatric Medical Director at Abbott. “The ability for medical professionals to provide best-in-class care using nutrition allows them to proactively support a strong start in life.”

For Mothers With Coronavirus, Baby's First Coo Is Over the Phone

"It's a girl and she is fine, we all are fine," said Rayhona, 23. "They have shown her to me on a smartphone." More than 150 babies have been born to mothers with suspected coronavirus infections at Moscow's City Clinical Hospital Number 15, and the hospital says not a single newborn caught the infection. But to achieve that, the babies are separated from their mothers at birth, breastfeeding is banned, and the mothers are kept quarantined in a ward for two weeks. Rayhona wore a mask and was hooked up to medical devices, sharing a room with another new mother also suspected of carrying the virus. The mothers "are admitted with some respiratory distress already and we need to be very professional to determine when to deliver the baby and how to deliver it," the hospital's head doctor, Valeriy Vechorko, said. "I can say this for sure — we did not have a single transmission of the virus to a baby." Until they are released from quarantine, mothers can communicate with their new babies only via video calls. The mothers "are scared - more scared than usual at least — as they are worried not only about themselves but about their baby as well," said hospital cardiologist Olga Lapochkina. "We try to keep mothers in touch with the babies via video links. Doctors show them and it really helps."

Companies Reinforce Partnership

Masimo and Royal Philips, both global leaders in patient monitoring, announced that they have reinforced their partnership, whereby Philips will integrate additional Masimo measurement technologies into select IntelliVue MX-series multi-parameter monitors, to help clinicians assess cerebral oximetry and ventilation status. Core Masimo noninvasive measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry and advanced rainbow SET Pulse CO-Oximetry parameters like noninvasive hemoglobin (SpHb), have long been available on a wide range of Philips multi-parameter monitors. In 2016, Masimo and Philips entered into a multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. Now, in 2020, Philips becomes one of Masimo's first industry partners to launch additional advanced Masimo measurements, NomoLine and O3, in their own patient monitors, sharing Masimo's expertise in capnography and regional cerebral oximetry with caregivers and patients around the world. NomoLine capnography and O3 regional oximetry measurements are available now on Philips MX500 and MX550 monitors in select markets throughout the world, and are also available directly from Masimo on its Root Patient Monitoring and Connectivity Platform and when connected to select Philips patient monitors via Philips' IntelliBridge module: NomoLine "no-moisture" sampling lines are designed for low-flow applications and can be used in a variety of clinical scenarios and care settings, on both intubated and non-intubated patients of all ages, in both low- and high-humidity applications. O3 regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

HCV-Exposed, Uninfected Infants Show B-Cell Changes

Many uninfected babies born to mothers with chronic hepatitis C virus (HCV) infection may have already fought off the virus themselves, new research suggests. Infants exposed to the virus but not infected had immune system changes similar to those of HCV-infected infants, including high numbers of virus-specific IgG-secreting B cells, more IgA-positive plasma cells and upregulation of CD40, compared with unexposed and uninfected infants, Dr Niklas K. Bjoerkstroem of Karolinska University Hospital in Stockholm and colleagues found. "It seems to be a specific thing that happens within the B cells within these exposed children," Bjoerkstroem said. "It gives us some insight into why it's such a rare instance that hepatitis C is vertically transmitted." The risk of mother-to-child transmission (MTCT) in pregnant women with HCV is not clear, but it is estimated at approximately 5%, lower than for chronic hepatitis B virus and HIV, Dr. Bjoerkstroem and his team note in Gut. Some uninfected children born to mothers with HCV have HCV-specific T-cell responses, they add. To investigate B-cell-mediated immunity and HCV exposure, the authors looked at 55 mothers and their babies delivered at a hospital in Saint Petersburg, Russia, from 2012 to 2016. Infants underwent peripheral blood mononuclear cell (PBMC) sampling at birth and at six, 12 and 18 months. Forty of the mothers were HCV-RNA positive when the babies were born and 15 were negative, indicating that they had cleared the virus. Their infants were classified as unexposed. Among the 40 exposed infants, three became HCV-RNA positive during the follow-up period, and were classified as infected.

Children who became infected had higher mean levels of HCV-specific Ig-G secreting B cells than the children who were exposed but uninfected and the unexposed group. Mean levels of HCV-specific Ig-G secreting B cells were similar for the exposed but uninfected and the unexposed groups, but some exposed individuals had "robust responses." IgA-positive plasma cells were identified in 28.9% of infected children, 29.7% of exposed children and 15.1% of unexposed children, with a similar pattern for IgG-positive plasma cells. Infected children also had changes in myeloid immune cells and natural killer cells and a soluble factor profile with high levels of inflammatory cytokines and chemokines, none of which were seen in the exposed group.

COVID-19 Severity in Pregnancy Appears Lower Than H1N1

Unlike past respiratory illnesses, pregnancy does not seem to put women at risk of worse outcomes from COVID-19, according to the first 6 weeks of births to women in the UK during the COVID-19 era.

"When we actually looked at our data in nonpregnant women of the same age, the outcomes look to be pretty similar for [mothers]" with COVID-19, study coauthor Marian Knight, MBChB, DPhil, professor of maternal and child health at the University of Oxford, United Kingdom, said. The data, currently available on a pre-print database, also suggest that more severe outcomes are more likely in later pregnancy, which Knight said should support guidance that women in the third trimester be vigilant with physical distancing, masking, and hand hygiene to avoid acquiring SARS-CoV-2 in the first place. The paper has not been peer-reviewed and therefore the findings should be taken as preliminary until it is accepted. The data may also temper concerns raised in early case reports on miscarriage and other poor outcomes. "Most of the publications in pregnancy have been case series, and we've really had no idea how representative they are of all the women affected," she said. "These results can be reassuring" that poor outcomes may indeed be less common than the current literature suggests.

Endowment Announced

As part of an ongoing commitment to the advancement of respiratory care, Dräger announced that it has granted the American Respiratory Care Foundation (ARCF) a $50,000 endowment to support the Craig D Smallwood Early Investigator Fellowship. This newly established program, which will be announced at the 2020 American Association for Respiratory Care (AARC) International Congress in Orlando, honors the late Craig D Smallwood, PhD, RRT, who died unexpected at the age of 36 in April 2020. Dr Smallwood was an innovative, collaborative and productive researcher who served as a mentor to up-and-coming researchers in the field of respiratory care. Before his untimely passing, he was working on the design and deployment of respiratory assist devices for treatment of COVID-19 patients in the developing world. The ARCF fellowship is designed to provide the chosen fellow with financial, experiential and mentoring resources; thereby continuing Dr Smallwood’s tradition of promoting the role of the respiratory therapist in supporting neonatal and pediatric research. “We are very pleased to receive such generous support from Dräger, a forward-thinking company that understands the importance of mentorship in respiratory care,” said ARCF Chairman Michael Amato. “This unique program remembers the valuable contributions of Dr Smallwood, and will help prepare the next generation of researchers. By supporting the ARCF, Dräger is investing in the future of respiratory care.” Dräger is one of several companies in the respiratory industry to establish an endowment to the ARCF for the purpose of creating research fellowships. This program recognizes the ongoing need for effective clinical research specifically to support neonatal and pediatric patients. “Technology advancement, innovation and new clinical practices require research,” said President and CEO for Dräger in North America, Lothar Thielen. “Establishing an annual award to support neonatal/pediatric research fosters an environment of collaboration and continues the scholarly work necessary to advance and improve patient outcomes.”

Birth Rates Fall

The number of babies born in the US hit the lowest level in more than three decades in 2019, continuing a five-year downward trend, according to a new federal report. The report on provisional data from the Centers for Disease Control and Prevention indicates notable birth and population measures reached record lows in 2019. American women, for example, are now projected to have about 1.71 children over their lifetimes – down 1% from 2018 and below the rate of 2.1 needed to exactly replace a generation. "The (total fertility) rate has generally been below replacement since 1971 and consistently below replacement since 2007," the report says. In all, the US saw nearly 3.75 million births last year, down 1% from 2018 and the lowest level since 1985, according to the CDC. Births fell among women of most races, though they rose 3% for women who were Native Hawaiian or other Pacific Islander. Births remained largely level for Hispanic women. The US birth rate – which measures the number of births per 1,000 women and girls between the ages of 15 and 44 in a given year – sat at 58.2 in 2019 for another record low, according to the report. Its continual decline has been driven in part by a 73% plummet in the teen birth rate since 1991. That rate fell another 5% in 2019, reaching 16.6 per 1,000, the report notes. Birth rates also fell for women in their 20s and early 30s in 2019, but rose for women in their early 40s. "The rate for (women 40 to 44 years old) has risen almost continuously since 1985 by an average of 3% per year," the report says. Trends in birth outcomes also continued in 2019: The preterm birth rate rose for the fifth year in a row, reaching 10.23%, while the cesarean section rate fell to 31.7% from 31.9%. The low-risk C-section rate – measuring C-sections among women giving birth for the first time to a single baby, born after reaching term and in the head-first position – fell to 25.6% from 25.9%. The federal government's Healthy People goals say the low-risk C-section rate should be no more than 24.7% by 2020, and there's significant variation in C-section rates at the state and county levels.

Astarte Medical has an upcoming webinar, Preterm Infant Growth Assessment — Metrics That Matter

Featured Speakers: Dr Tanis Fenton and Dr Bill Hay on June 10, 2020, at 4:00 p.m. ET.
Topics of discussion will include:

• Findings from their recent publication - Extrauterine growth restriction" and "postnatal growth failure" are misnomers for preterm infants published March 25, 2020
• Definition of Extrauterine Growth Restriction (EUGR)
• Proper growth assessment and metrics that matter

Registration and Complete Event Details: https://astartemedical.webinarninja.com/live-webinars/327916/register

Study Shows Reduced Risks

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk–based nutritional products, announced that a subgroup analysis of a randomized, multicenter clinical study demonstrated a fivefold reduced risk of certain serious complications and death, and greater increases in head circumference, which suggests better brain growth, using Prolacta’s 100% human milk–based fortifier in place of cow milk–based fortifier among preterm infants. All study infants were fed only their mother’s milk, in addition to either human- or cow-milk-based fortifiers and were treated in a neonatal intensive care unit (NICU). The analysis was conducted to more closely compare feeding protocols used in NICUs today and represents one of the only studies of preterm infant feeding protocols ever to directly compare fortifiers made from either human milk or cow milk among infants whose only other source of enteral nutrition is milk from their mothers.   The study, “Preterm Infants Fed Cow's Milk–Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk,” was published in Breastfeeding Medicine and found the following health outcomes among preterm infants who received Prolacta’s 100% human milk–based fortifiers:

• 13% greater head circumference gain, which is used as a measure of brain growth
• 5.1-fold reduced risk of surgery and death due to necrotizing enterocolitis (P = 0.014)
• Comparable weight and length gain

“Those fed the human milk–derived fortifier were significantly advantaged in terms of a reduced incidence of morbidity,” wrote the study authors, who were led by Alan Lucas, MD, Professor at the Institute of Child Health, University College London in the United Kingdom. Many studies, including the original study2 from which this analysis was derived, compared human- and cow-milk-based fortifiers in infants fed various combinations of human milk (from either their mother or donors) and cow milk–based preterm formula. However, many healthcare professionals prefer direct clinical comparison for the specific effects of a 100% human milk–based fortifier vs a cow milk–based fortifier, since avoidance of exposure to cow-milk proteins is one likely reason 100% human milk–based fortifiers are so beneficial. Based closely on the methods by which preterm infants are currently being fed in NICUs worldwide, the subgroup analysis focused specifically on the 114 infants who received their mother’s milk plus either:

• Prolacta’s 100% human milk–based fortifier (82 infants)
• Cow milk–based fortifier (32 infants)

“The original Sullivan study has been criticized for not representing current NICU feeding practices which prioritize mother’s milk or donor human milk over cow milk–based preterm formula. The Lucas subgroup analysis removed that variable to provide a head-to-head comparison of human- vs cow-milk-based fortifiers mixed with a base of mother’s milk. It demonstrated, with statistical significance, that the cow-milk-based fortifiers alone lead to adverse outcomes, while preterm infants fed Prolacta’s human milk–based fortifier achieved the same positive results including fewer complications as demonstrated in the original study. This subgroup analysis also found additional improvements in head growth, which is an indirect measure of brain growth, in the infants receiving Prolacta’s fortifier,” said Melinda Elliott, MD, Chief Medical Officer, Prolacta Bioscience.

Neotech Products Re-releases Disposable Ocular Exam Kit

Back by popular demand, Neotech Products is excited to announce the re-release of the Ocular Exam Kit Disposable Speculum and Depressor. “After numerous requests by clinicians for a disposable alternative, we made the decision to bring back this innovative and unique product,” said Executive Director of Sales & Marketing, Judy McCrary. Conceived by Dr David Sami, Pediatric Ophthalmologist, our specula and depressor was developed for single use per eye. This helps to reduce the risk of cross contamination and eliminate the need to re-sterilize. “One of the many benefits of the Neotech Ocular Exam Kit is that due to its disposability, it does not incur the normal re-sterilization costs that standard exam kit tools do,” McCrary said. The Ocular Exam Kit is disposable, sterile, and ready to use. Its unique speculum is designed to lock in place with eyelid pressure, allow unrestricted view, and open and close with ease. The speculum is available in two sizes—Neonatal and Standard. The two-sided depressor features an innovative texture intended to gently grip the conjunctiva.

Utility Device Holder with C-clip Attachment Available

Neotech Products unveiled the NeoHug Utility Device Holder is now available with a C-clip attachment for IV poles. “We had increased interest in departments that didn’t have a surface to adhere the suction cup [of the original NeoHug] to. Our incredible engineering team at Zewski Corp got to work creating this new attachment for the NeoHug. Their skilled team took the challenges in needing an adaptation and made them into the reality,” said Sara Dimmitt, Manager of Business Development. The new C-clip attaches to most IV poles, snaps on and off, and features a ribbed design to minimize slipping. “The C-clip is great for pediatrics and mobile patients to hold tubing or needed supplies,” Dimmitt said. NeoHug is also available with a large suction cup that attaches to most smooth, flat surfaces. It offers a strong hold that withstands heat and humidity, and features a tab for easy removal. Like the C-clip, the suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit, five bright colors in fact! The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, tubing, and more!

Observational Registry Moves to Next Phase

Mallinckrodt, a global biopharmaceutical company, announced that its observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life. The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population. "Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The real-world data provided by this registry underscores our commitment to continue to expand upon the body of scientific knowledge on treatment of vulnerable patient populations, such as premature infants with pulmonary hypertension." The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate OI (SOI) during the INOmax treatment period. No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Neonatal Intensive Care proud to add Dr Ruben Dario Restrepo to its Editorial Advisory Board

Los Angeles, CA — Health journal Neonatal Intensive Care today announced the addition of Dr Ruben Dario Restrepo to its respected Editorial Advisory Board. Dr Restrepo is Coordinator of Research Division of Respiratory Care with UT Health San Antonio, Department of Respiratory Care, San Antonio, Texas.

“We’re proud to add someone of Dr Restrepo’s caliber to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Neonatal Intensive Care. “With the spread of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Restrepo will help us achieve that mission.”

Dr Restrepo is a Fellow of the American Association of Respiratory Care (FAARC) and the American College of Chest Physicians (CHEST), a Distinguished Teaching Professor and Distinguished CHEST Educator, and has been inducted into the Kenneth I. Shine Academy of Health Science Education, and received the Regents Outstanding Teaching Award.

“I am a very passionate educator,” said Dr Restrepo. “Teaching respiratory care at a global and interprofessional level has been my motto from the time I started teaching.”

COVID-19 Global Disease Dynamics and Hands-on Treatment Best Practices

Join us on April 9 at 8 a.m. PST for an important webinar report by Pr. Luciano Gattinoni on managing critical parameters of ventilatory support for COVID-19 patients. As a researcher and a mentor to clinicians across Europe, Pr. Gattinoni has a unique, comprehensive perspective on COVID-19 care. In this webinar, he will share his observations of the disease as well as basics on how to ventilate a COVID-19 patient. A live Q&A session will follow this webinar presentation.

WHAT WILL BE COVERED
• Differences between COVID-19 and ARDS lung dynamics
• Criteria for non-invasive support versus mechanical ventilation
• Suggested ventilator settings
• The right moment to wean

WHO SHOULD ATTEND
Intensivists, ICU Clinicians, Respiratory Therapists, Respiratory Experts, Anesthesiologists, Hospitalists and Physicians and Healthcare Providers caring for COVID-19 patients.

Pr. Luciano Gattinoni is currently a Guest Professor at the University of Göttingen (Germany). He is world-renowned for inventing the “Extracorporeal CO2 Removal” technique in acute respiratory failure, promoting the “baby lung” model of lung injury (1980’s) and identified mechanical power variables to assess risks of mechanical ventilation (2016). He has previously served as President for the Italian National Society of Anesthesia and Intensive Care, the European Society of Intensive Care, and the World Federation of Societies of Intensive and Critical Care Medicine.

His research focuses on the pathophysiology and treatment of acute respiratory failure, sepsis, and acid base disorders. He has published more than 400 research articles in peer-reviewed journals. He is Honorary Member of the German Society of Anesthesiology and Intensive Care, Fellow of the Royal College of Physicians, and was awarded with the Life Time Achievement Award by the American Society of Anesthesiology, the American Society of Critical Care Medicine and the European Society of Intensive Care and the French Society of Intensive Care. Visit gehealthcare.com for more.

Two NICU Items to Remember

To keep an eye on NICU visitor temperature readings, NOVAMED USA provides an easy answer with ACCUTHERM Forehead Liquid Crystal Temperature Indicators. Simply adhere to the forehead and within 15 seconds, core body temperature is indicated. Safe for even the most sensitive skin and can be worn up to 48 hours. Not made of natural rubber latex. Offered 100 pcs/ box for $95. www.novamed-usa.com For further inquiries: Email info@novamed-usa.com. Avoid NICU out-of-stock scenarios with NEOTEMP Skin Temperature Sensors from NOVAMED USA. This reliable USA manufacturer/distributor offers a complete range of sensors to match GE/Ohmeda, Draeger/AirShields, ATOM Medical and International Biomedical incubators and radiant warmers. Call upon their neonatal specialists to assist in matching your specific requirements. For further inquiries: Email neonatal@novamed-usa.com or visit www.novamed-usa.com.

NICU Comms Tools Available

Keriton is offering 6-months of access to our patient communication tools. Learn more: www.keriton.com/special_for_nicus. Keep families connected to the NICU with realtime, HIPAA-compliant push notifications, chat and photos: Private, two-way chat between staff and families; Broadcast updates to all families with push notifications; Send families secure photos of their babies; Easy to turn-on for WOWs and desktops too.

Hy-Tape International’s COVID-19 Response

Hy-Tape International wanted to let you know what we’re doing in response to the Novel Coronavirus (COVID-19) outbreak to protect our staff and customers. We’re following federal, state, and local government health advice to make sure our customers and our colleagues stay safe and we are putting all the necessary measures in place to ensure this advice is followed by everyone. This means that we have staggered our workforce to keep our numbers lower. That being said, we appreciate your patience when placing orders. There are many steps throughout the process that may experience delays that are out of our hands. Presently we are well stocked, orders are going out on, or close to on time. Our spirits are high, we know that everyone working hard to help during these times are doing their best, and we will continue to serve our clients, answer calls, and move ahead to do our part. Thank you for your continued support and if you have any questions or concerns, please call us 1-800-248-0101.

Non-traditional means of PEEP generation utilized in conjunction with the LifePulse Jet Ventilator

Given the current COVID-19 Pandemic, hospitals may be faced with inadequate numbers of conventional ventilators due to the reallocation to other patient units. Clinicians may need to utilize non-traditional methods for PEEP and Mean Airway Pressure generation for use with the LifePulse Jet Ventilator.

Recommendations are below for these optional applications. We encourage you to call the hotline at 800-800-4358 (HFJV) should this situation arise. Alarms will only be activated by the LifePulse Jet Ventilator in all of the following set up scenarios. It is essential to respond to all alarms identified on the LifePulse HFJV. Use the PEEP display on the LifePulse HFJV to monitor PEEP. The following options are only recommended to be used on stable patients, as defined by the attending physician. Filter the exhaled gas in any of the following set up scenarios. Always provide proper humidification in any of the following set up scenarios. Option One: Traditional Invasive CPAP. (Diagram 1) Provide a blended gas source to a heated wire conventional ventilator circuit. At the interface on the distal end of the expiratory limb, utilize a PEEP valve. This set up would allow for the filtration of the exhaled gases, located before the PEEP valve. In addition, this option could also utilize a T-Piece Resuscitator to function as the PEEP valve and offer intermittent positive pressure breaths given via the clinician. NOTE: The position for some PEEP valves, i.e., vertical versus inverted, will affect the PEEP value displayed on a pressure manometer. NOTE: During testing, we noticed an audible vibration when using a PEEP valve and filter together. This noise did not affect the functionality of this option. Option Two: Traditional Invasive Bubble CPAP. (Diagram 2) Provide a blended gas source to a heated wire circuit using a flowmeter. Place the distal end of the circuit in either sterile water or acetic acid bath, to generate the desired CPAP level. NOTE: Bubbles generated in the water column caused pressure fluctuations, which contributed to discrepancies between measured PEEP on the Jet and the set PEEP. Our recommendation, for this application specifically, is to use another pressure manometer for monitoring PEEP. Option Three: Utilizing a T-Piece Resuscitator. (Diagram 3) It is strongly suggested to utilize flows between 8-10 liters per minute. It is essential to heat and humidify the inspiratory gas by utilizing the manufacturer's recommended heated wire circuit. Option Four: Utilizing a T-piece circuit without the Driver. (Diagram 4) Similar to Option Three. In this option, there is a Tpiece, with a PEEP valve, placed before the humidifier to set the desired Peak Inspiratory / Pop-Off Pressure. To deliver a manual breath, the T-piece resuscitator, located on the expiratory limb near the filter, is occluded by the clinician. WARNING: Having a PEEP Valve / Pressure Pop-Off, located at the humidifier, is critical in safely applying this option. The methods described in this Bulletin are valid only for the duration of the Declared Public Health Emergency. These alternate methods of providing PEEP have not been cleared through the FDA. These methods are only to be used if a conventional ventilator is not available to provide PEEP or mean airway pressure. Although Bunnell Inc. has performed bench studies to confirm effectiveness and safety, full clinical validation with all set-ups has not been completed. If the patient is positive for Coronavirus or is suspected to be positive, we recommend the use of an expiratory filter or a traditional conventional ventilator.

St. Luke's University Health Network One of the First in the World to Pilot Masimo SafetyNet

Masimo announced that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. The telehealth solution uses a tetherless, wearable single-patient-use sensor to monitor patients with clinically proven Masimo SET pulse oximetry, and is designed to help manage the surge in COVID-19 patients while maintaining the safety of other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness." Designed to track the blood oxygen saturation and respiration rate of patients who are hospitalized or quarantined at home, Masimo SafetyNet combines tetherless SET pulse oximetry with a proprietary remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device. Monitoring key physiological data can help provide clinicians with an accurate snapshot of a patient's systemic health and facilitates awareness of the need for rapid execution of treatment decisions that can be life-saving. Patients are provided with a multi-day supply of single-patient-use sensors and access to the Masimo SafetyNet mobile app. With clinical feedback from St. Luke's led by Dr. Carmona and from University Hospitals led by Dr Peter Pronovost, Masimo SafetyNet has been designed for easy, intuitive use to provide customized, interactive CarePrograms that align with expert guidance on COVID-19. Monitoring data collected by the sensor is shared with the patient’s smartphone using a secure Bluetooth® connection. Twice daily, or as directed, the CareProgram can be configured to actively notify patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and pushes these responses along with the monitoring data to clinicians for evaluation. CarePrograms are fully customizable to accommodate each institution's protocols, each patient’s needs, and any changes in COVID-19 guidance – and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. In addition to COVID-19 CarePrograms, Masimo SafetyNet can be configured for more than 150 other CarePrograms for use with COPD, heart failure, oncology, and other patients.

On March 30, patients at St. Luke's University Health Network Bethlehem diagnosed with COVID-19 were outfitted with Masimo SafetyNet. Non-COVID-19 patients are also being monitored with this system in general medical-surgical units. St. Luke's plans to use the Masimo SafetyNet tetherless sensor and cloud-based surveillance system to monitor upwards of 2,000 hospitalized patients and lower acuity cases in the home. These may also include staff and patients who are quarantined at home with the virus. "Our patients at St. Luke’s have the most sophisticated and reliable respiratory monitoring available anywhere," Carmona says. "We know that continuous physiologic monitoring with Masimo’s Patient SafetyNet improves outcomes and saves lives. The ability to extend that capability to patients in non-traditional settings and at home during this crisis with Masimo SafetyNet is transformative. Only through our relationship with Masimo could this have been possible."

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is proud to be able to work with St. Luke’s to help protect the health and safety of medical professionals and the patients they serve during this global pandemic."

Prolacta Reassures Hospitals of the Safety of Its Human Milk-Based Nutritional Products Amid COVID-19

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, notified hospital customers of the safety, quality, and continued supply of its human milk-based nutritional products. Prolacta’s products are used by neonatal intensive care units (NICUs) throughout the world to address the nutritional crisis of prematurity. “We realize these are uncertain times and there are many questions surrounding the coronavirus. We are providing hospitals with the latest scientific data needed to make informed decisions,” said Scott Elster, president and CEO of Prolacta Bioscience. “We also want to reassure these dedicated clinicians that the pandemic will not affect our commitment to supply their premature infants with life-saving nutritional products.” The US Centers for Disease Control and Prevention (CDC), the Union of European Neonatal and Perinatal Societies (UENPS), and the European Center for Disease Prevention and Control (ECDC) have all issued statements either that SARS-CoV-2 (coronavirus) does not appear to be present in breastmilk and/or that breastmilk does not appear to be a source of disease transmission. Currently, data from China show an absence of detectable coronavirus in breastmilk. Chen et al. studied lactating mothers with coronavirus. Breastmilk of six of those mothers was tested for the presence of SARS-CoV-2. The virus was not found in any of the milk specimens tested. Kam et al. looked at breastmilk from one mother with coronavirus and this testing also failed to show the presence of the virus. Prolacta exceeds all state and federal regulations for human milk quality and surpasses the quality and safety standards of all currently operating milk banks. All Prolacta products are pasteurized using time and temperature profiles defined by the US Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure destruction of pathogens. Prolacta’s pasteurization process has been independently validated using the same robust pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta’s pasteurization provides appropriate bacterial killing and viral inactivation including enveloped viruses. Coronavirus is an enveloped virus. Studies of other epidemic coronaviruses, such as the virus responsible for the 2003 SARS epidemic and the virus responsible for the 2012 MERS outbreak, demonstrate that pasteurization is highly effective in inactivating these viruses. These studies were done in diverse carrier media such as plasma products and various animal milks in which the virus was found during epidemic infection. Only human milk products manufactured with the FDA-defined pasteurization process, such as Prolacta’s, are clinically proven to be safe and improve health in the NICU. No published clinical data show similar results using human milk products treated by any other method. Prolacta operates the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Its two facilities have standard ISO-7 and ISO-8 cleanrooms totaling nearly 21,100 square feet. Prolacta modeled its stringent quality and safety protocols on those used in the plasma and blood industries. Prolacta has developed, validated, and implemented 19 donor milk screening tests to ensure the safety of its human milk-based nutritional products. Prolacta also has implemented the world’s first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens and bacteria in donated breastmilk. Since 2018, all donor milk received by Prolacta has been tested using NAAT. “All Prolacta products, including pasteurized and nutrient-standardized donor milk, are manufactured in the same manner and undergo the same quality and safety protocols,” said Elster. “We are maintaining a full inventory of finished product, as well as raw materials, and have multiple shipping partners to ensure deliveries continue as planned. Our team remains available to handle orders and any issues that arise.”

Device With Improved Oxygen Saturation Gets FDA Clearance

Device maker Masimo announced that RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (<3 kg). The updated RD SET sensors’ SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS (at 1 standard deviation), in conditions of motion and no motion, providing clinicians with even greater confidence when monitoring the oxygenation status of neonates. With this clearance, the improved performance specifications, which were incorporated into RD SET sensors for patients >3 kg in 2018, are now available to all patient populations in the United States. Masimo’s SET pulse oximetry has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies – even before the revisions that achieved the improved accuracy specifications – providing clinicians with increased sensitivity and specificity to help them make critical patient care decisions. Crucially for newborn health, SET has been shown to help clinicians reduce severe retinopathy of prematurity in neonates3 and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns. In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. In particular, RD SET NeoPt sensors with Velaid SofTouch use little to no adhesive, facilitating quick but gentle application and repositioning on the fragile skin of newborns and pre-term babies. RD SET sensors also feature an intuitive sensor-to-cable connection, while their lightweight design results in up to 84% less waste and their sleek, recyclable packaging reduces storage and shipping space. Joe Kiani, Founder and CEO of Masimo, said, “We’re delighted to announce the latest result of our continued innovation in our foundational SET pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we’ve been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry.”

Nihon Kohden Launches New Ventilator System

Nihon Kohden, a US market leader in precision medical products and services, announced the launch of its new NKV-550 series ventilator system that offers a full suite of applications necessary in a critical care setting for patients of all ages – from neonate through adult. The NKV-550, introduced for the first time at the annual American Association for Respiratory Care Congress 2019 in New Orleans, is an innovative ventilator that features an integrated touchscreen, intuitive user interface, and onscreen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, allowing clinicians to respond to a patient’s respiratory support needs without having to change devices. “Every product we bring to market is designed to simplify workflow for clinicians and benefit patients,” said Yasuhiro Yoshitake, president and CEO of Nihon Kohden America. “We saw a tremendous need in the respiratory market for a comprehensive ventilator that could respond to any patient situation while also providing excellent usability using modern technology.” The NKV-550 is a unique ventilator to offer Protective Control, a feature that uses a second graphic user interface placed outside the isolation room of a contagious patient who is under mechanical ventilation. The respiratory therapists and clinicians can view the ventilator monitors and alarms, adjust ventilation settings and alarm settings, and audio pause the alarm sound, through the second graphic user interface outside the isolation room, as long as the patient is within the sight of the clinician through the room’s glass window. When managing a patient who has a communicable disease case and is in isolation, this feature protects both the clinician and the patient because respiratory therapists and clinicians will not lose valuable minutes donning protective gowns, gloves and masks before responding to the needs of an infectious patient. This minimizes a potential hazard many healthcare workers face. An estimated 42 healthcare workers per million employed die each year from infections acquired at work. The NKV-550 was created based on the lung protective approach to ventilation and features the Gentle Lung suite of applications to provide clinically relevant, easy-to-use tools for the open-lung approach to ventilation. The ventilator offers highly customizable screen configurations enabling the ventilator to fit into your paradigm rather than require you adapting to it. The app-based design provides guided processes to help create a more streamlined, systematic way for clinicians to optimize care of their ventilated patients. The NKV-550 also offers on-screen help tools to walk clinicians through critical ventilator troubleshooting. Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the US, Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide.

Device Gets a Hug from Company

Neotech Products announced the release of their newest product, the NeoHug Utility Device Holder. The genesis for the NeoHug came after Neotech received several similar ideas. The product design team then came together to create a device that was easy to use, useful for clinicians, and playful. “The original idea was a simple strap with suction cup and then a similar idea was submitted to Neotech. Thanks to the help of our engineering design team at Zewski Corporation, they came up with the creative animal design. After some production design challenges, we’re very excited to bring this product to market,” said Neotech President Craig McCrary. The NeoHug attaches to most smooth surfaces utilizing a large suction cup for strong hold and easy removal, while also holding under heat and humidity. The suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit with five bright colors to choose from. The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, and more. “Seeing the reaction from the clinicians has truly made developing this product worthwhile. It’s exciting to have a very functional product come to market and knowing it’s a device that can bring smiles wherever it’s being used,” McCrary said.

New Product a Solution to Meet Updated Guidelines

Neotech Products is announced the release of their newest product, the NeoHeart ECG Pad. The NeoHeart ECG Pad was designed by a clinician as a solution to meet the new NRP guidelines for neonatal resuscitation by providing an all-in-one ECG pad that can be deployed in seconds, not minutes. “In a newborn resuscitation, time is everything! What I love about the new Neotech NeoHeart ECG Pad is that with one touch you can apply all 3 ECG leads securely and out of the way so that everyone can focus on stabilizing the infant and not the equipment,” said Kathi Salley-Randall, MSN, RNC, CNS, NNP-BC. The NeoHeart ECG Pad features a 3-in-1 pre-wired electrode array and pre-measured sensor position for clinician ease of use. Its one-touch application makes it ideal for use in the delivery room. The NeoHeart ECG Pad was engineered for back application, allowing the chest to remain exposed. “As most of us know, it is extremely difficult to assess heart rate in the first critical minutes of a sick newborns life. Palpation and auscultation of heart rate in the delivery room are not accurate and more importantly take valuable time and hands away from more critical tasks. The new NeoHeart ECG Pad gives accurate heart rate readings in seconds (not minutes) so that we can quickly assess the newborn's needs and effectiveness of interventions without having to stop to check the heart rate manually,” Salley-Randall said.

Oximetry Device Cleared by the FDA

Masimo announced that O3 Regional Oximetry has received FDA clearance for use on neonatal and infant patients (<10 kg). O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults. O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional hemoglobin oxygen saturation of blood (rSO2) on both sides of the brain, may be particularly helpful in providing insight into neonatal patient status because neonatal pathology is often brain-related. In neonates, O3 provides reliable measurement with a 3% ARMS trending accuracy specification.

O3 sensors are available in three sizes, for adult (≥40 kg), pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients. O3 is available as a Masimo Open Connect (MOC-9) module for the Root Patient Monitoring and Connectivity Platform. Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root's plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3 and other measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry, providing clinicians with expanded visibility of neonatal oxygenation status. Additional modalities available on Root include advanced rainbow noninvasive measurements such as total hemoglobin (SpHb), SedLine brain function monitoring (available for adult patients), NomoLine capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with Masimo Patient SafetyNet or Iris Gateway, monitoring data from O3 can be automatically charted in electronic medical records (EMRs).

Joe Kiani, Founder and CEO of Masimo, said, "From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET pulse oximetry was designed with neonates and infants in mind. These patients were not an afterthought. This focus has paid off for these young patients: SET pulse oximetry has helped clinicians reduce the incidence of severe retinopathy of prematurity (ROP) in neonates and improve critical congenital heart disease (CCHD) screening in newborns. O3 Regional Oximetry, with its ability to help clinicians accurately track cerebral oxygen saturation, will hopefully have a similar impact. We are happy to be able to bring O3's advanced capabilities and accuracy to the neonatal patient population."

NeoConnect at Home OTC Reusable ENFit Syringe Line Unveiled

NeoMed is excited to unveil NeoConnect at Home, a reusable portfolio of ENFit syringes that do not require a physician’s prescription. As a leading ENFit solution provider, NeoMed is dedicated to making it easier than ever for home patients to access the ENFit syringes they need. The NeoConnect at Home line of ENFit syringes is the first of its kind to be available over-the-counter (OTC) AND FDA 510(k) cleared for reuse. Ideal for patients in non-clinical and homecare settings, each syringe may be hand washed and reused up to 20 times by one user when cleaned per the cleaning instructions provided with the syringe. Reusability allows for a cost-effective and eco-friendly alternative to single use ENFit syringes. The syringe portfolio will be available in four convenient sizes (3 mL, 6 mL, 12 mL and 60 mL). Complete with a durable polypropylene plunger and silicone O-ring gasket, the syringes will feature clear barrels with easy-to-read black markings and will be offered in consumer-friendly case quantities. The product line will be available for purchase through retail and online stores, DME’s and homecare companies in the fall of 2019. ENFit is the registered trademark of the Global Enteral Device Supplier Association (GEDSA) and is commonly used to identify ISO 80369-3 compliant connectors. ENFit connectors help reduce the risk of enteral tube feeding misconnections and improve patient safety. GEDSA encourages manufacturers to introduce enteral devices with ENFit connectors, and healthcare facilities to adopt feeding systems with ENFit connectors as soon as possible. “The development of our NeoConnect at Home line of OTC reusable ENFit syringes is a direct result of feedback from customers concerned about ENFit syringe access and availability. Not only have we made our syringes more accessible, we’ve added value by ensuring they can be reused. It is our hope that ENFit syringe OTC availability and reusability will make enteral feeding and medication delivery hassle-free and cost-effective,” said Marc Waldman, Vice President of Business Development at NeoMed. “We are proud to be the first in the industry to offer reusable ENFit syringes that are available without a prescription. We believe that this innovation will improve ENFit device access and advance the worldwide adoption and implementation of safer enteral connectors,” remarked NeoMed President Aaron Ingram.