Faculty Bibliography

Clinical studies in preterm neonates are rarely performed due to ethical concerns and difficulties associated with trials and recruitment. Consequently, dose selection in this population is primarily empirical. Scaling neonatal doses from adult doses does not account for developmental changes and may not accurately predict drug kinetics. This is especially important for gentamicin, a narrow therapeutic index aminoglycoside antibiotic. While gentamicin's bactericidal effect is associated with its peak plasma concentration, keeping trough concentrations below 1 μg/mL prevents toxicity and also helps counteracting adaptive resistance in bacteria such as Escherichia coli. In this study, physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) modeling was used to support and/or guide dosing decisions, and to predict the antibacterial effect in preterm neonates. A gentamicin PBPK model was successfully verified in healthy adults and preterm neonates across all gestational ages. Clinical data from a neonatal intensive care unit at NYU Langone Long Island hospital was used to identify dosing regimens associated with increased incidence of elevated gentamicin trough concentrations in different preterm patient cohorts. Model predictions demonstrated that a higher dose with an extended-dosing interval (Q36h) in neonates with a postmenstrual age of 30-34 weeks and ≥ 35 weeks, with postnatal age 8-28 days and 0-7 days, respectively, were more likely to have a trough < 1 μg/mL when compared with once-daily (Q24h) dosing. PBPK-PD modeling suggested that a higher dose administered Q36h may provide effective antibacterial therapy. This article is protected by copyright. All rights reserved.

OBJECTIVE: There are limited published data on the transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus from mothers to newborns through breastfeeding or from breast milk. The World Health Organization released guidelines encouraging mothers with suspected or confirmed COVID-19 to breastfeed as the benefits of breastfeeding outweighs the possible risk of transmission. The objective of this study was to determine if SARS-CoV-2 was present in the breast milk of lactating mothers who had a positive SARS-CoV-2 nasopharyngeal swab test prior to delivery, and the clinical outcomes for their newborns. STUDY DESIGN/METHODS:by two-step reverse transcription polymerase chain reaction. Additionally, the clinical characteristics of the maternal newborn dyad, results of nasopharyngeal SARS-CoV-2 testing, and neonatal follow-up data were collected. RESULTS: A total of 19 mothers were included in the study and their infants who were all fed breast milk. Breast milk samples from 18 mothers tested negative for SARS-CoV-2, and 1 was positive for SARS-CoV-2 RNA. The infant who ingested the breast milk that tested positive had a negative nasopharyngeal test for SARS-CoV-2, and had a benign clinical course. There was no evidence of significant clinical infection during the hospital stay or from outpatient neonatal follow-up data for all the infants included in this study. CONCLUSION/CONCLUSIONS: In a small cohort of SARS-CoV-2 positive lactating mothers giving birth at our institution, most of their breast milk samples (95%) contained no detectable virus, and there was no evidence of COVID-19 infection in their breast milk-fed neonates. KEY POINTS/CONCLUSIONS:· Breast milk may rarely contain detectable SARS-CoV-2 RNA and was not detected in asymptomatic mothers.. · Breast milk with detectable SARS-CoV-2 RNA from a symptomatic mother had no clinical significance for her infant.. · Breast feeding with appropriate infection control instructions appears to be safe in mother with COVID infection..

BACKGROUND:Baby-Friendly hospitals encourage rooming-in newborns with mothers. In our institution, we noticed increased incidence of hypothermia following Baby-Friendly designation. We aimed to reduce the incidence of hypothermia in the mother-baby-unit to <15% and to decrease the rate of isolated hypothermia admissions to the neonatal intensive care unit (NICU) by 20% over two years. METHODS:After a retrospective review of newborns ≥35 weeks gestation in the mother-baby-unit with hypothermia, we implemented multiple interventions such as nursing education, hypothermia algorithm, Kamishibai cards, and Key cards. RESULTS:Hypothermia incidence in the mother-baby-unit decreased from 20.9 to 14.5% (p < 0.001) and infants requiring NICU admission decreased by 71% (p < 0.001) following all interventions. Apart from nursing education, all interventions led to significant reductions in both outcomes from baseline. CONCLUSION/CONCLUSIONS:Instituting a hypothermia algorithm and utilizing K-cards and Key cards reduces the incidence of hypothermia in the mother-baby-unit and NICU admissions for isolated hypothermia.

OBJECTIVE:To assess the impact of separation of SARS-CoV-2 PCR-positive mother-newborn dyads on breastfeeding outcomes. STUDY DESIGN/METHODS:This is an observational longitudinal cohort study of SARS-CoV-2 PCR-positive mothers and their infants at three NYU Langone Health hospitals from March 25, 2020 through May 30, 2020. Mothers were surveyed by telephone regarding pre-delivery feeding plans, in-hospital feeding, and home feeding of their neonates. Any change prompted an additional question to determine whether this change was due to COVID-19. RESULTS:Of the 160 mother-newborn dyads, 103 mothers were reached by telephone, and 85 consented to participate. No significant difference was observed in pre-delivery feeding plan between the separated and unseparated dyads (P = .268). Higher rates of breastfeeding were observed in the unseparated dyads compared with the separated dyads in the hospital (p<0.001), and at home (p=0.012). Only two mothers in each group reported expressed breast milk as the hospital feeding source (5.6% of unseparated vs 4.1% of separated). COVID-19 was more commonly cited as the reason for change among the separated compared with the unseparated group (49.0% vs 16.7%, p<0.001). When dyads were further stratified by symptom status into four groups (asymptomatic separated, asymptomatic unseparated, symptomatic separated, and symptomatic unseparated), results remained unchanged. CONCLUSION/CONCLUSIONS:In the setting of COVID-19, separation of mother-newborn dyads impacts breastfeeding outcomes, with lower rates of breastfeeding both during hospitalization and at home following discharge compared with unseparated mothers and infants. No evidence of vertical transmission was observed; one case of postnatal transmission occurred from an unmasked symptomatic mother who held her infant at birth.

OBJECTIVE:To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa, for the treatment of respiratory distress syndrome in infants born preterm. STUDY DESIGN/METHODS: × mean airway pressure]) in the first 24 hours, 7 and 28 days, discharge home, and/or 36 weeks of postmenstrual age; mortality and bronchopulmonary dysplasia at 28 days and 36 weeks of PMA. Adverse events and immunogenicity were monitored for safety. RESULTS:and respiratory severity score decreased from baseline at all time points (P < .001) with no statistically significant differences between groups. Rescue surfactant use (19 [33.9%] vs 17 [29.8%]), bronchopulmonary dysplasia (31 [55.4%] and 32 [56.1%]), and mortality at day 28 (4 [7.1%] and 3 [5.3%]) were similar in the CHF5633 and poractant alfa groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and poractant alfa groups, respectively. No immunogenicity was detected. CONCLUSIONS:Treatment with CHF5633 showed similar efficacy and safety as poractant alfa in neonates born preterm with moderate-to-severe respiratory distress syndrome. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov: NCT02452476.

OBJECTIVE:The primary objective was to evaluate hydrocortisone's efficacy for decreasing respiratory support in premature infants with developing bronchopulmonary dysplasia (BPD). Secondary objectives included assessment of the impact of intrauterine growth restriction (IUGR), maternal history of chorioamnionitis, side effects and route of administration associated with hydrocortisone's efficacy. Dexamethasone as second-line treatment to decrease respiratory support was reviewed. METHODS:Retrospective chart review of preterm infants requiring respiratory support receiving hydrocortisone. RESULTS:A total of 48 patients were included. Successful extubation was achieved in 50% of intubated patients after hydrocortisone treatment with no major complications. In our small study, history of maternal chorioamnionitis, IUGR or route of administration did not affect the response. Rescue dexamethasone after hydrocortisone therapy was ineffective in the ten patients who failed extubation following hydrocortisone. CONCLUSION/CONCLUSIONS:Hydrocortisone is effective in decreasing respiratory support in patients with developing BPD without major complications. Randomized studies are warranted to confirm our findings.

Since its emergence in Wuhan as a novel coronavirus disease, it has taken only a few months since January 2020 for it to be recognized as a widespread COVID-19 pandemic which has contributed to global health devastation. As pointed out by health experts, it is a once in a century pandemic of our times. Clinical observations so far indicate that the older population and immune compromised individuals, particularly in African American and Hispanic/Latino communities, are at much higher risk for infection with this novel coronavirus. In this regard, pregnancy offers an altered immunity scenario which may allow severe COVID-19 disease. The literature is so far highly conflicting on this issue. This review will offer a conceptual basis for severe or controlled disease and address trepidations for pregnant women associated with COVID-19 pandemic, particularly in the comparative context of clinical consequences of other coronaviruses such as SARS and MERS. We will highlight the possible consequences of COVID-19 on the general health of pregnant women as well as its possible effects at the maternal-fetal interface. For the placenta-related pathology, we will focus our discussion on the temporal expression of ACE2 throughout gestation for possible propagation of SARS-CoV-2 in the placenta in infected women and ensuing consequences.