Oral ibuprofen versus placebo in closure of patent ductus arteriosus in preterm neonates, a randomized control trial.

Abstract

Background: A consensus on treatment of patent ductus arteriosus (PDA) in preterm neonates remains elusive. Conservative management has recently gained popularity due to medical treatment lacking the evidence of benefit in terms of mortality and morbidity.

Objective: This study compares the efficacy of the standard dose of oral Ibuprofen versus placebo in the closure of PDA in preterm neonates ≤34 weeks gestation.

Methods: Eighty enrolled preterm neonates with a hemodynamically significant PDA (hsPDA) were randomized to either receive an early 3-day course oral ibuprofen or placebo (1:1). The open-label option and an extended oral ibuprofen therapy were offered if there were concerns over patient's clinical condition being attributed to PDA and only if showing evidence of systemic and/or pulmonary hyperperfusion.

Results: No significant difference in PDA closure between both groups (62.5% vs 65% in Ibuprofen & placebo group respectively, p = .816). No significant difference was observed between groups in mortality (p = 1), Bronchopulmonary dysplasia (BPD) (p = 1), or necrotizing enterocolitis (NEC) (0.5). Placebo group required a longer duration of inotropic support (median of 10 vs 7.5 days in Ibuprofen group, p = .013) and were prescribed more diuretic therapy (27 vs 18 in Ibuprofen group, p = .043).

Conclusion: The standard dose of oral ibuprofen was comparable to placebo in early treatment of hsPDA in preterm neonates less than 34 weeks in terms of effect on ductal closure after one course of treatment, incidence of mortality, and morbidities like NEC, and BPD. Failure of ductal closure itself was associated in both groups with increased mortality, failure to reach full feeds, and more use of vasopressors and inotropes.