Randomized Trial on Echocardiography-Guided Ductus Arteriosus Treatment to Reduce Necrotizing Enterocolitis

Frontiers in Pediatrics

Pediatrics

María Teresa Moral-Pumarega¹  Rocío Mosqueda-Peña¹  Rebeca Sánchez-Salmador²  María Carmen Bravo²  Adelina Pellicer²  Izaskun Dorronsoro³  Fernando Cabañas³  Manuela López-Azorín³ 

[1] Department of Neonatology, Hospital Universitario 12 de Octubre, Madrid, Spain;Department of Neonatology, Hospital Universitario La Paz, Madrid, Spain;Department of Neonatology, Hospital Universitario Quirónsalud, Madrid, Spain;

关键词: ibuprofen;    necrotizing enterocolitis;    ductus arteriosus;    preterm;    echocardiographically-guided;    Neonatologist Performed Echocardiography;   

DOI  :  10.3389/fped.2021.807712

 received in 2021-11-02, accepted in 2021-12-13,  发布年份 2022

来源: Frontiers

【 摘 要 】

ObjectivePatent ductus arteriosus (PDA) approach remains controversial. We aim to evaluate whether echocardiography-guided (EchoG) PDA closure (to reduce drug exposure) and 24-h continuous ibuprofen infusion (24 h-IB) (to reduce peak concentration), compared with EchoG PDA closure plus conventional bolus (bolus-IB), reduces severe bowel adverse event rate in preterm infants with hemodynamically significant (hs) PDA.Study DesignThe study design is a multicenter, blinded, randomized controlled trial. Infants with <28 weeks of gestation underwent routine echocardiographic assessment (18–72 h of birth); infants with 28–33 weeks were screened only in cases where PDA was clinically suspected. HsPDA was considered if ductal diameter >1.5 mm and indicators of pulmonary overflow, systemic hypoperfusion, or both were present. Pharmacodynamic effect of CYP450 genotypes was also analyzed.ResultsOne hundred forty-six infants [median gestational age 26 (25–28) weeks; median birth weight 881 (704–1,100) g] were randomized to 24 h-IB (n = 70) or bolus-IB (n = 76) study group at 86 (58–140) h from birth. Groups were comparable regarding perinatal and neonatal clinical data, but higher prevalence of male sex in the bolus-IB group was found. Neither severe bowel adverse event rate [10% (24 h-IB) and 2.6% (bolus-IB), p = 0.1] nor ductal closure rate was different between the study groups. Postnatal age and peripheral SaO2 at treatment start and pulmonary hemorrhage were associated with severe bowel events, independent of treatment group allocation. CYP2C8 genetic polymorphisms were associated with ibuprofen efficacy (p = 0.03).ConclusionsIbuprofen intravenous continuous infusion compared with bolus infusion in preterm infants with hsPDA shows similar rates of success and does not reduce the prevalence of severe bowel events.

【 授权许可】

Unknown   
Copyright © 2022 Bravo, Sánchez-Salmador, Moral-Pumarega, López-Azorín, Mosqueda-Peña, Dorronsoro, Cabañas and Pellicer.