Trial reportJournal of Korean medical science2026
Two-Year Outcomes of a Randomized Controlled Trial of Nonintervention Versus Oral Ibuprofen for Patent Ductus Arteriosus in Premature Infants.
Trial report in Journal of Korean medical science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
backgroundOptimal management of patent ductus arteriosus (PDA) in premature infants remains debated, and the long-term impact of different strategies has not been well studied. We previously conducted a randomized clinical trial comparing nonintervention (NI) and oral ibuprofen (IBU) for hemodynamically significant PDA in preterm infants, which showed no significant difference in bronchopulmonary dysplasia or death during hospitalization. In this study, we aimed to present a prespecified longitudinal follow-up investigation to assess the outcomes of persistently open PDA at discharge, as well as growth and neurodevelopmental outcomes at 2 years' corrected age (CA), based on PDA management strategy.
methodsSurviving infants from the original trial were evaluated at 2 years' CA. Examiners blinded to the management group assessed spontaneous ductal closure after hospital discharge, growth parameters, and neurodevelopmental outcomes.
resultsAmong 130 survivors, open PDA at discharge was present in 7/66 (11%) NI and 2/64 (3%) IBU infants; spontaneous closure occurred in 3/7 NI infants but 0/2 IBU infants. Device closure occurred in 6% (4/66) of the NI group and 3% (2/64) of the IBU group (
conclusionThis follow-up study demonstrated that NI for hemodynamically significant PDA in preterm infants resulted in growth and neurodevelopmental outcomes at 2 years' CA similar to those seen with IBU treatment. The high rate of spontaneous PDA closure and lack of significant differences in long-term morbidities support the safety of NI and raise questions about the benefit of routine pharmacologic closure.
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