Long-Term Outcomes of Expectant Management versus Early Ibuprofen for Patent Ductus Arteriosus: 24-Month Follow-Up of the BeNeDuctus Trial.
Wievineke M J Apers, Tim Hundscheid, Elisabeth M W Kooi et al.
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In 30 seconds
This international, multicenter randomized trial follow-up compared expectant management with early ibuprofen for echocardiographically confirmed patent ductus arteriosus in infants born before 28 weeks’ gestation. At 24 months’ corrected age, survival without neurodevelopmental impairment was similar: 49% in each group (relative risk, 1.00; 95% CI, 0.76-1.33). No significant differences were found in the additional outcomes assessed, including growth measures, neurologic examination, and vision or hearing impairment. The findings suggest no advantage of routine early ibuprofen for survival and neurodevelopment in this study sample.
Key findings
- Survival without neurodevelopmental impairment was 49% with expectant management and 49% with early ibuprofen (relative risk, 1.00; 95% CI, 0.76-1.33).
- Follow-up data were available for 234 of 273 infants (85.7%); primary-endpoint assessment was available for 200 of 234 (85.5%).
- No significant group differences were observed in biometry, neurologic examination, or vision or hearing impairment.
Why it matters
For extremely preterm infants with a confirmed patent ductus arteriosus, the follow-up provides randomized evidence on outcomes beyond initial ductal management. Similar survival without neurodevelopmental impairment at two years, alongside no detected differences in other assessed outcomes, helps frame the potential benefits of routine early treatment against expectant management.
What to keep in mind
Primary-endpoint data were available for 200 of 234 infants with follow-up, so the outcome was not assessed in all followed participants.