Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial.

IF 3.9 2区 医学 Q1 PEDIATRICS
Hussnain Mirza, Jorge Garcia, Matthew Zussman, Rajan Wadhawan, Julie Pepe, William Oh
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引用次数: 0

Abstract

Objective: To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm.

Study design: This was a single-center, masked, randomized controlled trial involving infants born at <29 weeks' gestation and requiring positive pressure ventilation. Exclusion criteria included infants of COVID-19 positive mothers, large patent ductus arteriosus with left to right shunting, left ventricle dysfunction (ejection fraction <40%), significant congenital anomalies/genetic disorders or iNO treatment by clinicians prior to the study echocardiogram. Initial echocardiogram was performed at 72+24 hours of life to randomize infants with early PH into 2 study arms (iNO vs placebo). Serial echocardiograms were performed every 24-48 hours, up to 14 days of life. Treatment was weaned until PH resolved (responders) or if no improvement was documented >72-hours (non-responders). Primary outcome was death or BPD at 36-weeks postmenstrual age.

Results: From July 2019 to October 2023, 683 eligible infants were admitted. We excluded 88 infants; 413 mothers declined consent or were not approached. iNO treatment was clinically started for 51 infants due to hypoxic respiratory failure. Screening echocardiograms were completed for 180 infants; of these, 32 infants with early PH were randomized to iNO or placebo groups. After a planned interim analysis, termination of the trial was recommended by the Data Safety Monitoring Committee because of futility. Conclusion iNO treatment does not reduce the risk of BPD or death among extremely preterm infants with echocardiographic evidence of early pulmonary hypertension without hypoxic respiratory failure.

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来源期刊
Journal of Pediatrics
Journal of Pediatrics 医学-小儿科
CiteScore
6.00
自引率
2.00%
发文量
696
审稿时长
31 days
期刊介绍: The Journal of Pediatrics is an international peer-reviewed journal that advances pediatric research and serves as a practical guide for pediatricians who manage health and diagnose and treat disorders in infants, children, and adolescents. The Journal publishes original work based on standards of excellence and expert review. The Journal seeks to publish high quality original articles that are immediately applicable to practice (basic science, translational research, evidence-based medicine), brief clinical and laboratory case reports, medical progress, expert commentary, grand rounds, insightful editorials, “classic” physical examinations, and novel insights into clinical and academic pediatric medicine related to every aspect of child health. Published monthly since 1932, The Journal of Pediatrics continues to promote the latest developments in pediatric medicine, child health, policy, and advocacy. Topics covered in The Journal of Pediatrics include, but are not limited to: General Pediatrics Pediatric Subspecialties Adolescent Medicine Allergy and Immunology Cardiology Critical Care Medicine Developmental-Behavioral Medicine Endocrinology Gastroenterology Hematology-Oncology Infectious Diseases Neonatal-Perinatal Medicine Nephrology Neurology Emergency Medicine Pulmonology Rheumatology Genetics Ethics Health Service Research Pediatric Hospitalist Medicine.
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