WIP 88 - EXPECTANT MANAGEMENT VERSUS EARLY IBUPROFEN FOR PATENT DUCTUS ARTERIOSUS IN EXTREME PRETERM INFANTS (BeNeDuctus): FOLLOW-UP AT 24 MONTHS’ CORRECTED AGE.
Background: Patent ductus arteriosus (PDA) in extreme premature neonates is associated with morbidity and mortality and there is ongoing worldwide debate on how to manage this. Recently, results of the BeNeDuctus trial, a randomized controlled trial where expectant management was compared with early treatment of the PDA using ibuprofen, showed that expectant management at 36 weeks’ postmenstrual age was non-inferior with respect to the composite outcome of mortality, moderate/severe bronchopulmonary dysplasia, and necrotizing enterocolitis (Bell’s stage IIa or higher). Objective: In this study we present follow-up data on general health and neurodevelopmental outcome at 24 months corrected age. Design/Methods: In this international multicentre randomized controlled trial, extremely preterm infants (less than 28 weeks’ gestation) with an echocardiographically confirmed PDA (diameter >1.5 mm) between 24h and 72h postnatal age, were randomly assigned to early ibuprofen treatment or truly expectant management. Approval by the Research Ethic Committee was obtained. Follow-up study data at a corrected age of 24 months infants were collected. General health included biometrics and number of admissions. Neurologic outcome was defined by neurological disability (cerebral palsy, vision, hearing), cognitive and motor function assessment (BSID-III-NL) and behavioural assessment (CBCL). Statistical analysis will be performed using IBM SPSS Statistics 29. Continuous data will be analysed using the t-test, presented with 95% confidence intervals, and using the Mann-Whitney U test for non-normally distributed data. Categorical data will be analysed using the Chi-square test. Logistic regression analysis will be used to analyse the effect of possible confounders. A total of 273 patients were randomized, with 136 patients in the expectant group and 137 patients in the early ibuprofen treatment group. 44 patients died before discharge from the hospital. No patients have died afterwards up and until the corrected age of 24 months. Final analysis of the data will be presented at the conference.
