Kristen Coletti, K. Taylor Wild, Elizabeth E. Foglia, Suzan Cochius-den Otter, Haresh Kirpalani
Children’s Hospital of Philadelphia and University of Pennsylvania. Erasmus MC University Medical Center.
United States and Netherlands
Clinics in Perinatology
Clin Perinatol 2024; 51: 253-269
DOI: 10.1016/j.clp.2023.11.009
Abstract
Inhaled nitric oxide (iNO) is a pulmonary vasodilator considered standard of care to treat persistent pulmonary hypertension of the newborn. However, not all infants respond to iNO. The authors performed a systematic review to examine methodology, outcomes, and challenges of randomized controlled trials testing pulmonary vasodilator medications adjunctive to iNO. The 5 trials identified showed heterogeneity in eligibility criteria and outcomes assessed. No trial achieved recruitment goals, limiting conclusions regarding efficacy, safety, and pharmacology. Trial design consensus and alternative methodologic strategies such as deferred consent, real-world controls, nonrandomized database assessments, and Bayesian statistical approaches are needed.
Category
Class I. Persistent Pulmonary Hypertension of the Newborn
Medical Therapy. Efficacy or Lack of Efficacy
Review Articles Concerning Pulmonary Vascular Disease
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: No