Congenital heart diseaseRandomised controlled trial
Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants
- Randomised controlled trial
- multicentre
- stopped for futility and safety after 50% interim analysis
- Stopped for futility and safety after the 50% interim analysis due to higher survival with expectant management
Authors' conclusion
In extremely preterm infants with a protocol-defined PDA, death or BPD did not differ between the expectant management group and the active treatment group. Survival was substantially higher with expectant management.
Study context
- Population
- Infants born at 22 to 28 weeks' gestation with protocol-defined patent ductus arteriosus (PDA) diagnosed between 48 hours and 21 days of age; 33 hospitals of the NICHD Neonatal Research Network
- Participants
- 482 infants
- Comparison
- Expectant management vs active treatment for PDA
- Expectant managementn = 242
- Active treatmentn = 240reference
- Primary endpoint
- Death or bronchopulmonary dysplasia (BPD)
- Follow-up
- 36 weeks' postmenstrual age
Primary result
As reported in the abstract
Adjusted risk difference
1.2%
95% CI −5.7% to 8.1%
P = 0.73
Events by treatment group
Expectant management vs Active treatment
adjusted risk difference 1.2% (95% CI −5.7% to 8.1%); P = 0.73
Secondary outcomes
| Outcome | Expectant management | Active treatment | adjusted risk difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Death before 36 weeks' postmenstrual age | 4.1% | 9.6% | −5.6% (−10.1% to −1.2%) | P = 0.01 | |
| −15−10−505Difference (linear scale) |
Infections resulting in death
Original publication
Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants. JAMA. Published 17 February 2026. doi:10.1001/jama.2025.23330
Summarised from the published abstract; every number is checked against it