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Early Treatment of Patent Ductus Arteriosus With Ibuprofen
Quick Takes
- Early administration of ibuprofen in extremely premature infants (<29 weeks’ gestation) with large patent ductus arteriosus (PDA) did not result in improvement in survival or decrease the risk of moderate or severe bronchopulmonary dysplasia.
- Ibuprofen administration resulted in decrease in size or resolution of the PDA in 55.5% of patients, as compared with 37.5% in the placebo group.
Study Questions:
What is the impact of selective early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants?
Methods:
A multicenter, randomized, double-blind, placebo-controlled trial was performed in the United Kingdom. Patients were enrolled and received treatment ≤72 hours after birth if they were 23 weeks to 28-6/7 weeks’ gestation and had a PDA ≥1.5 mm with pulsatile flow. The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks’ postmenstrual age.
Results:
A total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo. Data were available for analysis for 324 patients in the ibuprofen group and 322 in the placebo group. A primary outcome event occurred in 69.2% of patients in the ibuprofen group and 63.5% of patients in the placebo group (adjusted risk ratio [aRR], 1.09; 95% confidence interval [CI], 0.98-1.20; p = 0.10). A total of 13.6% of infants in the ibuprofen group died, as compared with 10.3% in the placebo group (aRR, 1.32; 95% CI, 0.92-1.90). Among those infants surviving to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 64.2% of infants in the ibuprofen group as compared with 59.3% in the placebo group (aRR, 1.09; 95% CI, 0.96-1.23). The PDA was closed or <1.5 mm by echocardiography at 3 weeks of age in 55.5% of infants receiving ibuprofen and 37.0% of infants receiving placebo.
Conclusions:
The authors conclude that the risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants receiving ibuprofen as compared with those receiving placebo.
Perspective:
A variety of treatment strategies have been implemented for management of PDA in extremely premature infants. This well-designed and well-executed study assessed the impact of administration of ibuprofen in infants with large PDA at approximately 72 hours of age. There was no benefit in survival or development of bronchopulmonary dysplasia. Interestingly, the treatment effect of ibuprofen was relatively low in this study—55.5% of infants showing decrease in size or resolution of the PDA with ibuprofen as compared with 37.0% in the placebo group. Overall, this study does not support the use of ibuprofen to improve mortality or decrease risk of bronchopulmonary dysplasia in extremely premature infants with PDA.
Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease
Keywords: Ductus Arteriosus, Patent, Ibuprofen
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