Baby-OSCAR
Trial question
What is the role of early treatment of large patent ductus arteriosus with ibuprofen in extremely preterm infants?
Study design
Multi-center
Double blinded
RCT
Population
646 patients.
Inclusion criteria: extremely preterm infants with large patent ductus arteriosus.
Key exclusion criteria: no realistic prospect of survival; severe congenital anomaly; conditions that would contraindicate the use of ibuprofen; indomethacin, ibuprofen, or paracetamol administration after birth.
Interventions
N=326 ibuprofen (a loading dose of 10 mg/kg followed by 2 doses of 5 mg/kg at least 24 hours apart).
N=327 placebo (matching placebo).
Primary outcome
Death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age
69.2%
63.5%
69.2 %
51.9 %
34.6 %
17.3 %
0.0 %
Ibuprofen
Placebo
No significant
difference ↔
No significant difference in death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age (69.2% vs. 63.5%; RR 1.09, 95% CI 0.98 to 1.2).
Secondary outcomes
No significant difference in the rate of death by 36 weeks of postmenstrual age (13.6% vs. 10.3%; RR 1.32, 95% CI 0.92 to 1.9).
No significant difference in moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age (64.2% vs. 59.3%; RR 1.09, 95% CI 0.96 to 1.23).
No significant difference in clinically-significant pulmonary hemorrhage (7.5% vs. 5.6%; RR 1.39, 95% CI 0.7 to 2.77).
Conclusion
In extremely preterm infants with large patent ductus arteriosus, ibuprofen was not superior to placebo with respect to death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age.
Reference
Samir Gupta, Nimish V Subhedar, Jennifer L Bell et al. Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med. 2024 Jan 25;390(4):314-325.
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