Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero.

BACKGROUND: Preeclampsia, especially before term, increases the risk of child neurodevelopmental adverse outcomes. Biological plausibility, preclinical studies, and pilot clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Obstetric-Fetal Pharmacology Research Centers Network support the safety and use of pravastatin to prevent preeclampsia. OBJECTIVE: This study aimed to determine the effect of antenatal pravastatin treatment in high-risk pregnant individuals on their child's health, growth, and neurodevelopment. STUDY DESIGN: This was an ancillary follow-up cohort study of children born to mothers who participated in the Obstetric-Fetal Pharmacology Research Centers Network pilot trials of pravastatin vs placebo in individuals at high risk of preeclampsia (ClinicalTrials.gov; identifier NCT01717586). After obtaining written informed consent (and assent as appropriate), the parent was instructed to complete the Child Behavior Checklist. To assess the child's motor, cognitive, and developmental outcomes, a certified and blinded study psychologist completed child motor, cognitive, emotional, and behavioral assessments using validated tools. Given the small number of individuals in the studies, the 10- and 20-mg pravastatin groups were combined into 1 group, and the results of the pravastatin group were compared with that of the placebo group. RESULTS: Of 40 children born to mothers in the original trial, 30 (15 exposed in utero to pravastatin and 15 to placebo) were enrolled in this follow-up study. The time of follow-up, which was 4.7 years (interquartile range, 2.5-6.9), was not different between children in the pravastatin group and children in the placebo group. There was no difference in the child's body mass index percentiles per sex and corrected age, the rates of extremes of body mass index percentiles, or the report of any other medical or developmental complications between the 2 groups. No child born in the pravastatin group had any limitation in motor assessment compared with 2 children (13.3%) who walked with difficulty and 4 children (26.7%) who had reduced manual abilities in the placebo group. Moreover, children born to mothers who received pravastatin had a higher general mean conceptual ability score (98.2±16.7 vs 89.7±11.0; P=.13) and a lower frequency (15.4% vs 35.7%; P=.38) of having a score of <85 (ie, 1 standard deviation lower than the mean) compared with those in the placebo group. Finally, there was no difference in the parents' report on the Child Behavior Checklist between the 2 groups. CONCLUSION: This study reported on the long-term neuromotor, cognitive, and behavioral outcomes among children exposed to pravastatin in utero during the second and third trimesters of pregnancy. Although the data were limited by the original trial's sample size, no identifiable long-term neurodevelopmental safety signal was evident with the use of pravastatin during pregnancy. This favorable neonatal risk-benefit analysis justifies continued research using pravastatin in clinical trials.

Safety and quality in maternal and neonatal care: the introduction of the modified WHO Safe Childbirth Checklist.

Maternal and neonatal mortality and morbidity associated with childbirth is a problem of the highest priority. This research has been aimed at testing a modified version of the WHO Safe Childbirth Checklist in one Italian hospital and to evaluate the tool in terms of its impact on clinical practice and safety. Results show that the presence of correctly compiled partogram tool is strongly and significantly associated with the checklist implementation (OR = 14.9, 95% confidence interval [CI] = 3.5, 63.9). Compliance to the checklist was high for mid-wives (96%) and very low for obstetricians (3%). The discrepancy is the result of a misinterpretation by obstetricians: they signed only in case they prescribed therapy or when they identified risk factors, but not to underline that they checked for those factors independently by their existence. While the checklist promotes the interdisciplinary work, field studies generally show strong hierarchical rather than partnership interaction. Practitioner Summary: The study is aimed at evaluating: the checklist impact on clinical practice through a prospective pre- and post-intervention study based on clinical records review, the usability of the tool and the user's compliance. The research gives evidences on the importance of the tool for reducing risks related to delivery.

Lead, Mercury, and Cadmium Concentrations in Blood Products Transfused to Neonates: Elimination Not Just Mitigation.

Lead (Pb), mercury (Hg), and cadmium (Cd) are identified as potent developmental neurotoxicants. Neonates are the main group receiving multiple blood transfusions. The exposure of neonates to these heavy metals (HMs) can occur through blood transfusions. This study aimed to determine the concentrations of lead (Pb), mercury (Hg), and cadmium (Cd) in various blood products (plasma, platelets, packed red blood cells (pRBCs), and whole blood (WB)) to explore the probability of concurrent exposure of these HMs and to identify the metal load per transfusion with risk assessment. Residual bloods from blood bank bags were collected after neonatal transfusion. Pb, Hg, and Cd concentrations were determined in 120 samples of blood products by inductively coupled plasma mass spectrometry (ICP-MS). Pb and Cd levels were over the normal levels in 19.2 and 5.9% of all blood units, respectively. In 35 and 0.8% of blood units, the Pb and Cd concentrations, respectively, were higher than that recommended for transfusions in premature neonates. The anticipated safe value was surpassed by 2.5% for Cd of all transfusions, primarily because of WB. However, Hg was detected only in 5.8% of all samples and their concentrations were within the normal range. The concurrent neonatal exposure to Pb, Hg, and Cd was statistically significant. Hazard quotients of Hg and Cr were >1 and Pb cancer risk was 2.41 × 10-4. To the best of our knowledge, this study is the first report examining Pb, Hg, and Cd in blood products other than WB and pRBCs using ICP-MS. This study demonstrated the exposure of neonates to Pb, Hg, and Cd during transfusion with a considerable amount of Pb. It confirms the significant concurrent exposure to the three HMs, which maximize their potential developmental neurotoxicity with a high probability of developing non-carcinogenic and carcinogenic health effects.

A pilot study to determine the incidence, type, and severity of non-routine events in neonates undergoing gastrostomy tube placement.

BACKGROUND: Non-routine events (NRE) are defined as any suboptimal occurrences in a process being measured in the opinion of the reporter and comes from the field of human factors engineering. These typically occur well up-stream of an adverse event and NRE measurement has not been applied to the complex context of neonatal surgery. We sought to apply this novel safety event measurement methodology to neonates in the NICU undergoing gastrostomy tube placement. METHODS: A prospective pilot study was conducted between November 2016 and August 2020 in the Level IV NICU and the pediatric operating rooms of an urban academic children's hospital to determine the incidence, severity, impact, and contributory factors of clinician-reported non-routine events (NREs, i.e., deviations from optimal care) and 30-day NSQIP occurrences in neonates receiving a G-tube. RESULTS: Clinicians reported at least one NRE in 32 of 36 (89%) G-tube cases, averaging 3.0 (Standard deviation: 2.5) NRE reports per case. NSQIP-P review identified 7 cases (19%) with NSQIP-P occurrences and each of these cases had multiple reported NREs. One case in which NREs were not reported was without NSQIP-P occurrences. The odds ratio of having a NSQIP-P occurrence with the presence of an NRE was 0.695 (95% CI 0.06-17.04). CONCLUSION: Despite being considered a "simple" operation, >80% of neonatal G-tube placement operations had at least one reported NRE by an operative team member. In this pilot study, NRE occurrence was not significantly associated with the subsequent reporting of an NSQIP-P occurrence. Understanding contributory factors of NREs that occur in neonatal surgery may promote surgical safety efforts and should be evaluated in larger and more diverse populations. LEVEL OF EVIDENCE: IV.

Cesárea por requerimiento materno y sus posibles determinantes: estudio de casos y controles en Centro Hospitalario Pereira Rossell / Cesarean delivery on maternal request and its possible determinants: a case-control study at Centro Hospitalario Pereira Rossell / Cesárea por solicitação materna e seus possíveis determinantes: estudo de casos e controles no Centro Hospitalar Pereira Rossell

Introducción: La cesárea por solicitud materna, aquella sin indicación médica materna ni fetal, ha aumentado en los últimos años. Se han descrito motivos para que la paciente solicite la misma, como experiencias emocionales, normas sociales, y la interrelación con el equipo de salud. Metodología: El objetivo fue determinar posibles determinantes para la solicitud de cesárea. Se realizó un estudio observacional de casos (pacientes que solicitaron cesárea sin indicación médica) y controles (parto vaginal espontáneo), no pareados, en una relación 2:1. Se utilizó una encuesta prediseñada para determinar los posibles determinantes, incluyendo el miedo al parto mediante cuestionario adaptado de W-DEQ, soporte social, preocupación por la seguridad fetoneonatal y la influencia del médico tratante. Resultados: Se incluyeron 171 pacientes. Dentro de las pacientes con cesárea por requerimiento materno, el 52,5% manifestó la elección de cesárea por preocupación por la alta seguridad fetoneonatal, el 32,8% por alguna influencia del médico tratante, el 31,7 % por su predictibilidad (mejor organización del hogar o por la angustia de la falta de certeza del momento del parto) y el 42,6% por preocupación personal por las consecuencias debidas al parto vaginal. La variable WDEQ, categorizada en terciles, mostró una asociación para solicitar cesárea con significancia estadística. La historia traumática previa mostró una asociación de 4,17. Conclusiones: Los factores que influyeron en la decisión de solicitar una cesárea fueron la historia traumática previa, la influencia del médico tratante y la existencia de tocofobia. Lo que une a todos estos factores es que son todos modificables.

Introduction: Cesarean delivery on maternal request, which occurs without maternal or fetal medical indication, has increased in recent years. Reasons for patients to request it have been described, such as emotional experiences, social norms, and the interrelationship with the healthcare team. Methodology: The objective was to determine possible determinants for cesarean request. An observational study was conducted with cases (patients who requested cesarean delivery without medical indication) and controls (spontaneous vaginal delivery), non-matched, in a 2:1 ratio. A pre-designed survey was used to determine possible determinants, including fear of childbirth through a W-DEQ adapted questionnaire, social support, concern for fetal-neonatal safety, and the influence of the treating physician. Results: A total of 171 patients were included. Among patients with cesarean delivery on maternal request, 52.5% reported choosing cesarean due to high concern for fetal-neonatal safety, 32.8% due to some influence from the treating physician, 31.7% due to its predictability (better home organization or the anxiety of uncertainty about the timing of delivery), and 42.6% due to personal concern about the consequences of vaginal delivery. The W-DEQ variable, categorized into tertiles, showed a statistically significant association for requesting cesarean delivery. Previous traumatic history showed an association of 4.17. Conclusions: The factors that influenced the decision to request a cesarean delivery were previous traumatic history, the influence of the treating physician, and the existence of tocophobia. What connects all these factors is that they are all modifiable.

Introdução: A cesárea por solicitação materna, aquela realizada sem indicação médica materna ou fetal, aumentou nos últimos anos. Motivos para que a paciente solicite a mesma foram descritos, como experiências emocionais, normas sociais e a inter-relação com a equipe de saúde. Metodologia: O objetivo foi determinar possíveis determinantes para a solicitação de cesárea. Foi realizado um estudo observacional de casos (pacientes que solicitaram cesárea sem indicação médica) e controles (parto vaginal espontâneo), não pareados, em uma relação 2:1. Utilizou-se uma pesquisa pré-desenhada para determinar os possíveis determinantes, incluindo o medo do parto por meio de um questionário adaptado do W-DEQ, suporte social, preocupação com a segurança fetoneonatal e a influência do médico responsável. Resultados: Foram incluídas 171 pacientes. Entre as pacientes com cesárea por requerimento materno, 52,5% manifestaram escolher a cesárea por preocupação com a alta segurança fetoneonatal, 32,8% por alguma influência do médico responsável, 31,7% por sua previsibilidade (melhor organização do lar ou pela angústia da falta de certeza sobre o momento do parto) e 42,6% por preocupação pessoal com as consequências do parto vaginal. A variável W-DEQ, categorizada em tercis, mostrou uma associação para solicitar cesárea com significância estatística. A história traumática anterior mostrou uma associação de 4,17. Conclusões: Os fatores que influenciaram a decisão de solicitar uma cesárea foram a história traumática anterior, a influência do médico responsável e a existência de tocofobia. O que une todos esses fatores é que todos são modificáveis.