6253 Long-term neurodevelopmental and respiratory outcomes after selective early treatment of patent ductus arteriosus

Objectives Short-term outcomes of Baby-OSCAR trial¹ reported no evidence of a reduction in death or moderate or severe bronchopulmonary dysplasia, with early selective treatment of a large patent ductus arteriosus (PDA) with ibuprofen within 72 hours of birth in extremely preterm infants. The objective of this study was to evaluate whether early treatment of a large PDA with ibuprofen improves long-term outcomes including survival without moderate or severe neurodevelopmental impairment and survival without respiratory morbidity at 24 months of age corrected for prematurity. Methods Baby-OSCAR is a UK multi-centre placebo-controlled masked randomised clinical trial in infants born 23⁺⁰ to 28⁺⁶ weeks of gestation.¹ The main long-term outcome was survival without moderate or severe neurodevelopmental impairment. Impairment was defined as any one of moderate or severe cognitive, language, gross motor, hearing or visual impairment using parent report² or classified by blinded end-point review committee. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. The trial was funded by the UK National Institute for Health Research (NIHR). Statistical analysis by intention-to-treat was performed using Stata 17®. Results The trial enrolled 653 babies. At 24 months corrected age, outcome data analysed by intention-to-treat (ITT population) were available for 537 children; 263 in the ibuprofen group and 274 in the placebo group. Maternal and infant baseline characteristics of children with outcome data were broadly similar between the groups; with mean gestational age at enrolment of 26.0 & 26.1 weeks, and birth weight 836.1g (standard deviation [SD] 207.7) & 850.9g (SD 211.8) in the ibuprofen and placebo groups, respectively. Survival without moderate to severe neurodevelopmental impairment in the ibuprofen and placebo groups was 116/263 (51.6%) and 119/274 (50.4%) respectively (data on 38 babies missing in each group); adjusted risk ratio 0.85 (95% confidence interval [CI] 0.63 to 1.16); p=0.317. Survival without respiratory morbidity in the ibuprofen and placebo groups was 66/263 (30%) and 74/274 (32.9%) respectively (data on 43 & 49 babies missing); adjusted risk ratio 0.89 (95% CI 0.68 to 1.18); p=0.430. Median (interquartile range [IQR]) duration of oxygen supplementation from randomization in ibuprofen and placebo groups was 79h (IQR 41 to 154h) & 78.5h (IQR 49 to 149h) respectively. Conclusion We found no evidence of an improvement in survival without moderate to severe neurodevelopmental impairment or survival without respiratory morbidity at 2 years corrected age after selective early treatment of a large PDA with ibuprofen in children born extremely preterm. References Gupta S, Juszczak E, Hardy P, Subhedar N, et al. Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatr 2021 Feb 26;21(1):100. Johnson S, Bountziouka V, Brocklehurst P, et al. Standardisation of the parent report of children's abilities-revised (PARCA-R): a norm-referenced assessment of cognitive and language development at age 2 years. Lancet Child Adolesc Health 2019;3:705–12.