Study Findings
Baby-OSCAR trial – Short term outcome results
(Published in NEJM 25th Jan 2024)
Why did we do this trial?
Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before and just after birth. For most babies, the blood vessel will shrink and close on its own shortly after birth but the blood vessel is likely to stay open for longer in babies who are born prematurely. This can lead to too much blood flowing into the baby's lungs and can cause heart failure and bronchopulmonary dysplasia (dependence on oxygen or breathing support). It can also predispose to development of infection of intestines called necrotising enterocolitis.
What did we do?
The Baby-OSCAR trial, which was coordinated by Oxford Population Health's National Perinatal Epidemiology Unit Clinical Trials Unit, in 32 neonatal intensive care units across the UK assessed whether or not treatment with ibuprofen within 72 hours of birth could help reduce the risk of death or developing bronchopulmonary dysplasia in extremely premature babies born with a large patent ductus arteriosus. The trial included 653 babies born between 23 weeks and less than 29 weeks of pregnancy who had been diagnosed with a large patent ductus arteriosus (more than 1.5mm with significant flow) confirmed by a chest ultrasound scan (echocardiogram). A total of 318 babies were randomly assigned to receive ibuprofen and 315 babies to receive a placebo.
What did we find?
Results from the Baby-OSCAR trial have shown that treatment with ibuprofen within 72 hours of birth in extreme preterm babies born with patent ductus arteriosus, does not improve survival rates or reduce occurrences of bronchopulmonary dysplasia at 36 weeks post menstrual age. The treatment with ibuprofen however significantly reduces incidence of persistently open PDA. The results are published in the New England Journal of Medicine.
Key findings:
- Treatment with ibuprofen within 72 hours of birth was not associated with a reduced risk of death or bronchopulmonary dysplasia when compared with placebo;
- 69.2% of babies assigned to ibuprofen either died or developed bronchopulmonary dysplasia compared with 64.1% infants who were assigned to the placebo;
- Among babies who survived to 36 weeks post-menstrual age (the number of weeks since the mother's last period), 64.2% assigned to ibuprofen and 59.3% assigned to placebo developed bronchopulmonary dysplasia;
- A single course of ibuprofen given within 72 hours of birth resulted in a closed or smaller patent ductus arteriosus at 3 weeks of age in 55.5% of babies in the ibuprofen group;
- There was no evidence that treatment with ibuprofen resulted in any additional serious health complications.
What does this mean for extremely premature babies born with a large patent ductus arteriosus?
Baby-OSCAR is the largest trial globally to assess treatment for patent ductus arteriosus in 25 years. The results of the trial provide an important contribution towards the treatments for patent ductus arteriosus and will help neonatologists and people caring for extremely premature babies to make informed decisions about the risks and benefits of treatment.
The trial team would like to thank all babies and their parents for participating in this trial.
The trial was funded by the National Institute for Health and Care Research Health Technology Assessment programme and sponsored by the University of Oxford.
You can read more about the findings of the Baby-OSCAR trial on the NEJM website.
