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Background: Vitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks' gestation have low vitamin D levels at birth and a limited intake during the first month. Enteral vitamin D supplementation is inexpensive and widely used. The appropriate supplementation regimen for extremely preterm infants is controversial, and the effect of different regimens on their blood levels and outcomes is unclear. Methods: Randomized, blinded comparative effectiveness trial to compare two vitamin D supplementation regimens for inborn infants <28 weeks gestation or <1000 g birth weight at a large academic center in the United States. Infants are stratified by birth weight and randomized within 96 h after birth to either routine supplementation (400 IU/day with established feedings) or increased supplementation (800 IU/day with any feedings) during the first 28 days after birth. We hypothesize that the higher and early vitamin D dose (800 IU/day with early feeding) compared to placebo plus routine dose (400 IU/day with established feeding) will substantially increase total 25-hydroxyvitamin D3 levels measured as state-of-art at 1 month, reduce respiratory support at 36 weeks' postmenstrual age (on an ordinal scale predictive of later adverse outcomes), and improve or at least not worsen other important secondary outcomes. The infants in the study will follow up at 22–26 months' corrected age (~2 years) with blinded certified examiners to evaluate neurodevelopmental outcomes. The sample size of a minimum of 180 infants provides >90% power to detect a >95% posterior probability of a 33% increase in serum 25-hydroxy vitamin D3 and >80% power to detect a >80% posterior probability of a relative risk decrease of 20% of reducing respiratory support by intention-to-treat Bayesian analyses using a neutral prior probability. Discussion: Our study will help clarify the uncertain relationship of vitamin D supplementation and its associated serum metabolites to clinical outcomes of extremely preterm infants. Confirmation of our hypotheses would prompt reconsideration of the supplementation regimens used in extremely preterm infants and justify a large multicenter study to verify the generalizability of the results. Trial registration: ClinicalTrials.gov NCT05459298. Registered on July 14, 2022. [ABSTRACT FROM AUTHOR]

Introduction: Children born prematurely (<37 weeks' gestation) are at increased risk of perinatal complications, comorbidities, and iron deficiency. Iron deficiency is associated with restless legs syndrome and periodic limb movement disorder. In this study, we assessed the prevalence of restless sleep disorder (RSD) and elevated periodic limb movements during sleep (PLMS) in children born prematurely who underwent polysomnography. Methods: A retrospective chart review of sleep studies was conducted in children aged 1–18 years (median age 4 years) with a history of premature birth. Children with genetic syndrome, airway surgery, or tracheostomy were excluded. Three groups were compared: children with PLMS index >5, children with RSD, and children with neither elevated PLMS index nor RSD. Results: During the study, 2577 sleep studies were reviewed. Ninety-two studies fit our criteria and were included in the analysis. The median age at birth was 31 weeks, and the interquartile range (IQR) was 27–34 weeks. A total of 32 (34.8%) children were referred for restless sleep and 55 (59.8%) for snoring. After polysomnography, 18% were found to have a PLMS index >5/h, and 14% fit the criteria for restless sleep disorder (RSD). There were no statistically significant differences in PSG parameters among the children with RSD, PLMS, and the remaining group, except for lower obstructive apnea/hypopnea index (Kruskal–Wallis ANOVA 8.621, p = 0.0135) in the RSD group (median 0.7, IQR 0.3–0.9) than in the PLMS (median 1.7, IQR 0.7–3.5) or the non-RSD/non-PLMS (median 2.0, IQR 0.8–4.5) groups. Conclusions: There was an elevated frequency of RSD and elevated PLMS in our cohort of children born prematurely. Children born prematurely are at higher risk of iron deficiency which can be a contributor factor to sleep -related movement disorders. These results add new knowledge regarding the prevalence of RSD and PLMS in these children. [ABSTRACT FROM AUTHOR]

The purpose of this study was to assess the prevalence of sleep disturbances in adults seeking physical therapy services. Participants were issued an electronic survey to provide demographic information and the following questionnaires: Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Sleep Hygiene Index (SHI), Insomnia Severity Index (ISI), STOP-BANG (obstructive sleep apnea (OSA) risk), and restless leg syndrome (RLS) risk. Percentages were calculated to describe prevalence of sleep disturbances, and Spearman's correlations were used to identify associations between pain and sleep questionnaires. Eighty-eight participants (47.9 ± 15.8 years, 68 females) completed the survey. Seventy-eight percent (n = 69) scored >5 on the PSQI; 32% (n = 28) scored ≥10 on the ESS; 52% (n = 46) scored ≥16 on the SHI; 51% (n = 45) scored ≥10 on the ISI; 28% (n = 25) had intermediate or high risk of OSA; and 40% (n = 35) indicated possible RLS. Pain level was significantly associated with PSQI (r(86) = 0.277, p =.009) and ISI (r(86) = 0.268, p =.012). There was a higher prevalence of sleep disturbances in adults seeking physical therapy services than in the general population. Increased pain severity was associated with poorer sleep quality and increased insomnia symptoms. This study highlights the need to screen patients for sleep disturbances. [ABSTRACT FROM AUTHOR]

Background: Acetaminophen, ibuprofen, and indomethacin are widely used as first-line drugs for patent ductus arteriosus (PDA) closure in preterm neonates. However, their relative safety profiles remain unclear., Methods: Adverse event reports related to the first-line drugs used in PDA and neonates in general were retrieved from the US Food and Drug Authority (FDA) Adverse Event Reporting System. Deduplicated reports were analyzed using proportional reporting ratios and reporting odds ratios to identify disproportionality safety signals between drugs., Results: A total of 969 unique reports related to the first-line drugs used in PDA and 499 reports in the neonatal period were included. Acetaminophen signals primarily involved the liver, while ibuprofen and indomethacin signals pertained to gastrointestinal, renal, vascular, and mortality outcomes. Higher occurrences of death were reported with indomethacin and ibuprofen compared with acetaminophen., Conclusion: This first comparison of PDA drug safety profiles from spontaneous reports highlights some differences, with acetaminophen potentially conferring a safer adverse effect profile overall. While limitations include missing data and reporting biases, the signals warrant further validation. Given its comparable efficacy to ibuprofen, as demonstrated in other studies, acetaminophen has the potential to be preferred as an initial medical therapy for PDA., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

The COVID-19 pandemic has taken a large toll on population health and well-being. We examine the consequences of prenatal exposure for infant health, through which the pandemic may have lasting intergenerational effects. We examine multiple pathways by which the pandemic shaped birth outcomes and socioeconomic disparities in these consequences. Analysis of more than 3.5 million birth records in California with universal information on COVID infection among persons giving birth at the time of delivery reveals deep inequalities in infection by education, race/ethnicity, and place-based socioeconomic disadvantage. COVID infection during pregnancy, in turn, predicts a large increase in the probability of preterm birth, by approximately one third. At the population level, a surprising reduction in preterm births during the first months of the pandemic was followed by an increase in preterm births during the surge in COVID infections in the winter of 2021. Whereas the early-pandemic reduction in preterm births benefited primarily highly educated mothers, the increase in preterm births during the winter infection surge was entirely concentrated among mothers with low levels of schooling. The COVID-19 pandemic is expected to exacerbate U.S. inequality in multiple ways. Our findings highlight a particularly enduring pathway: the long-term legacy of prenatal exposure to an unequal pandemic environment. [ABSTRACT FROM AUTHOR]

This study evaluates practices of infection control in the NICU as compared with the available literature. We aimed to assess providers' awareness of their institutional policies, how strongly they believed in those policies, the correlation between institution size and policies adopted, years of experience and belief in a policy's efficacy, and methods employed in the existing literature. An IRB-approved survey was distributed to members of the AAP Neonatal Section. A systematic review of the literature provided the domains of the survey questions. Data was analyzed as appropriate. A total of 364 providers responded. While larger NICUs were more likely to have policies, their providers are less likely to know them. When a policy is in place and it is known, providers believe in the effectiveness of that policy suggesting consensus or, at its worst, groupthink. Ultimately, practice across the US is non-uniform and policies are not always consistent with best available literature. The strength of available literature is adequate enough to provide grade B recommendations in many aspects of infection prevention. A more standardized approach to infection prevention in the NICU would be beneficial and is needed. [ABSTRACT FROM AUTHOR]

Antiseizure medications can cause serious adverse reactions and have deleterious drug interactions that often complicate the clinical management of patients. When the US Food and Drug Administration (FDA) wants to alert healthcare providers and patients about the risk of potentially serious or fatal drug reactions, the FDA requires the manufacturers of these medications to format these warnings within a "black-box" border, and prominently display this box on the first section of the package insert; such warnings are called "black-box warnings (BBWs)". The BBW is a way for the FDA to urge physicians to evaluate patients more rigorously and carefully weigh the risks and benefits, before prescribing medication that has the potential to cause serious adverse reactions, and to formulate a plan for close monitoring during therapy. The FDA BBW provides the extra layer of safety but many healthcare providers fail to comply with these warnings. Currently, there are 26 FDA-approved antiseizure medications in the US market, 38% of which have received BBWs, and most of the antiseizure medications with BBWs are older-generation drugs. Some antiseizure medications have multiple BBWs; for example, valproic acid has three BBWs including hepatotoxicity, fetal risk, and pancreatitis, carbamazepine has BBWs of serious skin and hematological reactions, and felbamate also has two BBWs including hepatic failure and aplastic anemia. The purpose of this review is to provide insight into each BBW received by antiseizure medications and discuss the FDA recommendations for evaluating the drug benefit/risk, and for monitoring parameters before the initiation of and during treatment., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Traumatic brain injury (TBI) affects 2.5 million people annually within the United States alone, with over 300 000 severe injuries resulting in emergency room visits and hospital admissions. Severe TBI can result in long‐term disability. Posttraumatic epilepsy (PTE) is one of the most debilitating consequences of TBI, with an estimated incidence that ranges from 2% to 50% based on severity of injury. Conducting studies of PTE poses many challenges, because many subjects with TBI never develop epilepsy, and it can be more than 10 years after TBI before seizures begin. One of the unmet needs in the study of PTE is an accurate biomarker of epileptogenesis, or a panel of biomarkers, which could provide early insights into which TBI patients are most susceptible to PTE, providing an opportunity for prophylactic anticonvulsant therapy and enabling more efficient large‐scale PTE studies. Several recent reviews have provided a comprehensive overview of this subject (Neurobiol Dis, 123, 2019, 3; Neurotherapeutics, 11, 2014, 231). In this review, we describe acute and chronic imaging methods that detect biomarkers for PTE and potential mechanisms of epileptogenesis. We also describe shortcomings in current acquisition methods, analysis, and interpretation that limit ongoing investigations that may be mitigated with advancements in imaging techniques and analysis. [ABSTRACT FROM AUTHOR]

Objective: Our objective was to assess differences in pregnancy outcomes during the COVID-19 pandemic compared to the previous year., Study Design: In a cross-sectional study of delivery hospitalizations in the Premier Healthcare Database Special COVID-19 Release, we assessed differences in selected maternal and pregnancy outcomes occurring April-December in 2019 and 2020 in the United States., Result: Among 663,620 deliveries occurring in 2019 and 614,093 deliveries occurring in 2020, we observed an increase in in-hospital maternal death from 2019 to 2020, which was no longer statistically significant after excluding deliveries with a COVID-19 diagnosis. Intensive care unit admission and preterm birth decreased from 2019 to 2020. There was no difference in the prevalence of most other outcomes examined., Conclusion: The full impact of the COVID-19 pandemic on maternal and pregnancy outcomes remains to be understood. Most outcomes investigated experienced minimal change from 2019 to 2020., (© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)