Umbilical cord blood gentamicin concentrations following maternally-administered intrapartum exposures.

We identified cord blood gentamicin concentrations that were higher than anticipated, and above clinical targets for immediate gentamicin re-dosing after birth. Incorporation of gentamicin levels at birth may aid in optimizing postnatal gentamicin dosing among infants exposed to intrapartum gentamicin.

Antibiotic use among extremely low birth-weight infants from 2009 to 2021: a retrospective observational study.

Objective: To assess trends in antibiotic use across a large cohort of extremely low birth-weight (<1000 g; ELBW) infants admitted to academic and community neonatal intensive care units (NICUs) across the USA over a 13-year period.

Design: Repeated cross-sectional cohort study.

Setting: Premier Health Database, a comprehensive administrative database of inpatient encounters from academic and community hospitals across the US.

Postdiscontinuation Antibiotic Exposure in Hospitalized Infants at Risk for Late-onset Sepsis in the Neonatal Intensive Care Unit.

Background: In the neonatal intensive care unit, infants are at risk for late-onset sepsis. When blood cultures are negative, antibiotic stewardship efforts encourage stopping antibiotics, yet the duration of therapeutic exposure after the last dose is unknown.

Methods: This retrospective cohort study of simulated antibiotic exposures used published population pharmacokinetic models within drug-specific neonatal intensive care unit cohorts of preterm and term infants, postnatal age 7-60 days and exposed to cefepime, piperacillin-tazobactam or tobramycin.

Preterm infants at low risk for early-onset sepsis differ in early fecal microbiome assembly.

Antibiotics are administered near-universally to very low birth weight (VLBW) infants after birth for suspected early-onset sepsis (EOS). We previously identified a phenotypic group of VLBW infants, referred to as low-risk for EOS (LRE), whose risk of EOS is low enough to avoid routine antibiotic initiation. In this cohort study, we compared 18 such infants with 30 infants categorized as non-LRE to determine if the lower risk of pathogen transmission at birth is accompanied by differences in microbiome acquisition and development.

Breast Milk and Saliva for Postnatal Cyto†megalovirus Screening among Very Low Birth Weight Infants.

Background: The optimal approach to managing postnatal cytomegalovirus disease (pCMV) among very low birth weight (VLBW) infants remains unknown. Methods to facilitate screening are needed.

Objective: Determine whether mother's milk and infant saliva can be used to reliably identify maternal cytomegalovirus (CMV) serostatus and detect infant pCMV acquisition.

Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship.

Objective: Define optimal ampicillin dosing for empiric early-onset sepsis (EOS) therapy in preterm neonates.

Study Design: We simulated ampicillin concentrations in newborns (birthweight < 1500 g; gestational age 22-27 weeks), summarizing three 48 h regimens: high 100 mg/kg Q8hr, medium 100 mg/kg Q12hr, and standard 50 mg/kg Q12hr. Concentration data were analyzed for concentration above minimum inhibitory concentration (MIC), below neurotoxicity threshold (C ≤ 140 mcg/mL), and duration limited to 48 h.

Challenges and opportunities for improving access to approved neonatal drugs and devices.

Neonatal drug and device development has lagged behind other patient populations. Oftentimes, providers are using drugs and devices without adequate study of safety and efficacy. Neonates deserve dedicated drug and device development programs, which will require novel approaches and unique collaborations between multiple key stakeholders.

A seat at the table: Regional, rural and remote health research and impact.

Aims: Across higher education, systems and policies explicitly address the impact of research. This paper contributes to the impact and engagement discussion from a regional, rural and remote perspective. We focus on how impact and engagement fit with regional, rural and remote research and explore strategies that can be employed to enhance impact and engagement in a rural health research context.

Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data.

Objective: The Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool.

Study Design: Retrospective validation study assessing the inter-rater reliability (IRR) of the NAESS.

Immunization in the Neonatal Intensive Care Unit.

Premature infants admitted to the neonatal intensive care unit are at risk for severe infections and infectious complications caused by vaccine-preventable diseases. Both maternal and neonatal vaccination prevent such infections and improve outcomes for premature infants. An understanding of vaccine efficacy, safety, and administration recommendations, as well as reasons for vaccine hesitancy among clinicians and caregivers, facilitate strategies for improving vaccination rates for infants in the neonatal intensive care unit.

3D-Printed Enzyme-Embedded Plastics.

A simple and environmentally friendly approach toward the thermoplastic processing of rapidly degradable plastic-enzyme composites using three-dimensional (3D) printing techniques is described. Polycaprolactone/Amano lipase (PCL/AL) composite films (10 mm × 10 mm; height [] = ∼400 μm) with an AL loading of 0.1, 1.

Racial and Ethnic Diversity in Studies Funded Under the Best Pharmaceuticals for Children Act.

Background And Objectives: The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on-patent medicines in children and mandates that the National Institutes of Health sponsor research on off-patent drugs important to pediatric therapeutics. Failing to enroll cohorts that reflect the pediatric population at large restricts the generalizability of such studies. In this investigation, we evaluate racial and ethnic minority representation among participants enrolled in BPCA-sponsored studies.

Prolonged Post-Discontinuation Antibiotic Exposure in Very Low Birth Weight Neonates at Risk for Early-Onset Sepsis.

Background: Premature, very low birth weight (VLBW) neonates are at risk for early-onset sepsis and receive ampicillin and gentamicin post-birth. Antimicrobial stewardship supports short-course antibiotics, but how long antibiotic concentrations remain therapeutic post-last dose is unknown.

Methods: Using Monte Carlo simulations (NONMEM 7.

Dosing of Antimicrobials in the Neonatal Intensive Care Unit: Does Clinical Practice Reflect Pharmacokinetics-based Recommendations?

Background: We sought to compare meropenem and fluconazole dosing in the neonatal intensive care unit with recommendations based on published pharmacokinetic (PK) studies in infants.

Methods: We performed an observational cohort study of infants <90 days postnatal age who received a course of meropenem or fluconazole who were treated in neonatal intensive care units managed by the Pediatrix Medical Group (1997-2016). We defined any dose amount from 80% to 120% of the published recommendation to constitute an appropriate dose of either antimicrobial.

Clinical impact of neonatal hypoglycemia screening in the well-baby care.

Objectives: To determine the proportion of well-appearing newborns screened for hypoglycemia, yield of specific screening criteria, and impact of screening on breastfeeding.

Study Design: The retrospective study of well-appearing at-risk infants born ≥36 weeks' gestation with blood glucose (BG) measurements obtained ≤72 h of age.

Results: Of 10,533 eligible well newborns, 48.

Development of a neonatal adverse event severity scale through a Delphi consensus approach.

Background: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials.

Dosing and Safety of Off-label Use of Caffeine Citrate in Premature Infants.

Objective: To characterize the dosing and safety of off-label caffeine citrate in a contemporary cohort of extremely premature infants.

Study Design: We used electronic health records (2010-2013) from 4 neonatal intensive care units to identify infants of ≤28 weeks of gestational age exposed to caffeine citrate. Safety outcomes included death, bronchopulmonary dysplasia, necrotizing enterocolitis, spontaneous intestinal perforation, intraventricular hemorrhage, patent ductus arteriosus ligation, seizures, and arrhythmias.

Physiologically-Based Pharmacokinetic Modeling of Fluconazole Using Plasma and Cerebrospinal Fluid Samples From Preterm and Term Infants.

Fluconazole is used to treat hematogenous Candida meningoencephalitis in preterm and term infants. To characterize plasma and central nervous system exposure, an adult fluconazole physiologically-based pharmacokinetic (PBPK) model was scaled to infants, accounting for age dependencies in glomerular filtration and metabolism. The model was optimized using 760 plasma samples from 166 infants (median postmenstrual age (range) 28 weeks (24-50)) and 27 cerebrospinal fluid (CSF) samples from 22 infants (postmenstrual age 28 weeks (24-33)).

Drugs for the Prevention and Treatment of Sepsis in the Newborn.

Antimicrobial medications are the most commonly used medications in the neonatal intensive care unit. Antibiotics are used for infection prophylaxis, empiric treatment, and definitive treatment of confirmed infection. The choice of medication should be informed by the epidemiology and microbiology of infection in specific clinical scenarios and by the clinical condition of the infant.

Towards intervertebral disc engineering: Bio-mimetics of form and function of the annulus fibrosus lamellae.

The aging western society is heavily afflicted with intervertebral disc (IVD) degeneration. Replacement or repair of the degenerated IVD with an artificial bio-mimetic construct is one of the challenges of future research due to its complex structure and unique biomechanical function. Herein, biocomposite laminates made of long collagen fibers in unidirectional (-1.