Congenital heart diseaseRandomised controlled trial
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
Authors' conclusion
The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo.
Study context
- Population
- Extremely preterm infants (23 weeks 0 days' to 28 weeks 6 days' gestation) with a large patent ductus arteriosus (PDA) (diameter ≥1.5 mm with pulsatile flow)324 and 322 analysed
- Participants
- 326 vs 327
- Comparison
- Early ibuprofen vs placebo for large PDA
- Ibuprofenn = 326
- Placebon = 327reference
- Primary endpoint
- Death or moderate or severe bronchopulmonary dysplasia
- Follow-up
- 36 weeks of postmenstrual age
Primary result
As reported in the abstract
Adjusted relative risk
1.09
95% CI 0.98–1.20
P = 0.10
Events by treatment group
Ibuprofen vs Placebo
adjusted RR 1.09 (95% CI 0.98–1.20); P = 0.10
Further findings
| Outcome | Ibuprofen | Placebo | adjusted RR (95% CI) | |
|---|---|---|---|---|
| Death | 13.6% | 10.3% | 1.32 (0.92–1.90) | |
| Moderate or severe bronchopulmonary dysplasia (survivors to 36 weeks) · 36 weeks of postmenstrual age | 64.2% | 59.3% | 1.09 (0.96–1.23) | |
| 0.512Adjusted relative risk (log scale) |
- Death: 44 of 323 vs 33 of 321
- Moderate or severe bronchopulmonary dysplasia (survivors to 36 weeks): 176 of 274 vs 169 of 285
Safety
Serious adverse events possibly related to ibuprofen
- Unforeseeable serious adverse events possibly related to ibuprofen
- 2
Original publication
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med. Published 25 January 2024. doi:10.1056/nejmoa2305582
Summarised from the published abstract; every number is checked against it