Expectant PDA Management Improves Survival in Preterm Infants: JAMA
In a recent study, researchers established that expectant management of patent ductus arteriosus (PDA) in extremely preterm infants improves survival without increasing the risk of bronchopulmonary dysplasia. The treatment of PDA in preterm infants has been debated for years because of uncertainty as to whether active pharmacologic closure improves outcomes or simply exposes infants to unnecessary risks. The study was published in JAMA by Matthew M. and colleagues.
This randomized clinical trial included infants born at 22 to 28 weeks of gestation who were diagnosed with a protocol-defined PDA between 48 hours and 21 days of life. Conducted from December 2018 to December 2024 at 33 hospitals in the National Institute of Child Health and Human Development Neonatal Research Network, the final follow-up was completed in June 2025.
A total of 482 infants were randomized. The median gestational age was 25 weeks (IQR, 24 to 27 weeks), while median birth weight was 760 g (IQR, 620 to 935 g). Infants were randomized to either expectant management (n = 242) or active treatment (n = 240) with either acetaminophen, ibuprofen, or indomethacin to promote PDA closure.
The primary outcome was a composite of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. Secondary outcomes included the individual components of the primary outcome and other morbidities of prematurity. For safety reasons and evidence of higher survival in the expectant management group, the trial was stopped after a 50% interim analysis.
Key Findings
The incidence of death or BPD was 80.9% (195 of 241 infants) in the expectant management group compared with 79.6% (191 of 240 infants) in the active treatment group, with an adjusted risk difference of 1.2% (95% CI, −5.7% to 8.1%; P = 0.73), indicating no significant difference.
However, death before 36 weeks' postmenstrual age occurred in 4.1% (10 of 241) of infants managed expectantly compared with 9.6% (23 of 240) in the active treatment group, corresponding to an adjusted risk difference of -5.6% (95% CI, -10.1% to -1.2%; P = 0.01).
Fatal infections occurred in 0.8% vs 3.8% of infants in the expectant management group vs the active treatment group, respectively (2 of 241 vs 9 of 240).
Among extremely preterm infants with a protocol-defined PDA, expectant management did not reduce the combined outcome of death or bronchopulmonary dysplasia as compared with active treatment, but survival was significantly higher with expectant management. These findings support expectant PDA management as a safe and potentially superior strategy for improving survival in this high-risk population.
Reference:
Laughon MM, Thomas SM, Watterberg KL, et al. Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants: The PDA Randomized Clinical Trial. JAMA. Published online December 09, 2025. doi:10.1001/jama.2025.23330
