Baby-OSCAR

Outcome after Selective Early Closure of Ductus Arteriosus in Extremely Preterm Babies

Trial started: 2014  Trial ended: 2021 

Summary

Objectives

To determine whether selective early treatment of a large patent ductus arteriosus with ibuprofen improves health and developmental outcomes in extremely preterm infants.

Methods

A multicentre, randomised, double-blind, placebo-controlled trial evaluating early treatment (?72 hours after birth) with ibuprofen for a large patent ductus arteriosus in extremely preterm infants born before 28 weeks' gestation.

Outcome measures

Primary outcome: A composite of death or moderate or severe bronchopulmonary dysplasia at 36 weeks' postmenstrual age.

Short-term secondary outcomes included complications of prematurity, patent ductus arteriosus closure and side effects of treatment.

Main long-term outcome: Survival without moderate or severe neurodevelopmental impairment at 24 months' corrected age. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. A health economic evaluation was also undertaken.

Results

A total of 326 infants were randomised to ibuprofen and 327 to placebo. The primary outcome occurred in 220/318 infants (69.2%) in the ibuprofen group and 202/318 infants (63.5%) in the placebo group (adjusted risk ratio 1.09, 95% confidence interval 0.98 to 1.20; p = 0.10). A total of 44/323 infants (13.6%) in the ibuprofen group and 33/321 infants (10.3%) in the placebo group died by 36 weeks' gestation (adjusted risk ratio 1.32, 95% confidence interval 0.92 to 1.90). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.

At 24 months' corrected age, outcome data were available for 263 and 274 children in the ibuprofen and placebo groups, respectively. Survival without moderate or severe neurodevelopmental impairment in the ibuprofen and placebo groups was 131/248 (53.0%) and 134/259 (51.9%), respectively (adjusted risk ratio 1.01, 95% confidence interval 0.86 to 1.18; p = 0.901). Survival without respiratory morbidity was 66/210 (31.4%) and 74/220 (33.6%), respectively (adjusted risk ratio 0.92, 95% confidence interval 0.70 to 1.20; p = 0.536). Median duration of oxygen supplementation was 76.0 and 78.0 days, respectively.

Conclusions

The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks' postmenstrual age was not statistically significantly lower for extremely preterm infants randomised to early treatment with ibuprofen compared with placebo. There was no evidence of an improvement in survival without moderate or severe neurodevelopmental impairment or survival without respiratory morbidity at 24 months' corrected age after selective early treatment of a large patent ductus arteriosus with ibuprofen in children born extremely preterm.

Adapted from: Gupta S, Subhedar NV, Bell JL, et al. Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial (Baby-OSCAR trial). Health Technology Assessment. 2026;30(11). https://doi.org/10.3310/GJSG2422. Licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Adapted for presentation on this website.