Effect of nonintervention vs oral ibuprofen in patent ductus arteriosus in preterm infants: A randomized clinical trial
JAMA Pediatrics Aug 07, 2020
Sung SI, Lee MH, Ahn SY, et al. - Researchers performed this randomized, double-blind, placebo-controlled, noninferiority clinical trial to determine the noninferiority of nonintervention vs oral ibuprofen treatment for patent ductus arteriosus (PDA) in decreasing bronchopulmonary dysplasia (BPD) incidence or death in very preterm infants. This trial was carried out on preterm infants (gestational age [GA] 23-30 weeks) with hemodynamically significant PDA (ductal size > 1.5 mm plus respiratory support) diagnosed between postnatal days 6 and 14. The sample consisted of 383 infants screened between July 24, 2014, and March 15, 2019. Compared with ibuprofen treatment, nonintervention demonstrated noninferiority in the closing of hemodynamically significant PDA and reduction of BPD or death. The noninferiority of nonintervention over ibuprofen may be due to the low efficacy of oral ibuprofen to close PDA, particularly in infants born at 23 to 26 weeks of gestation.
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