Results from the Baby-OSCAR trial have shown that treatment with ibuprofen within 72 hours of birth does not improve survival rates or reduce occurrences of bronchopulmonary dysplasia for preterm babies born with a large patent ductus arteriosus. The results are published in the New England Journal of Medicine.
Patent ductus arteriosus (PDA) is an extra blood vessel that babies have before and just after birth, that carries blood away from the lungs. 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 lung disease, such as bronchopulmonary dysplasia.
The Baby-OSCAR (Outcome after selective early closure of PDA) trial was coordinated by Oxford Population Health’s National Perinatal Epidemiology Unit Clinical Trials Unit, and conducted in 32 neonatal intensive care units across the UK. The trial included 653 babies born between 23 weeks and less than 29 weeks of pregnancy who had been diagnosed with a PDA with a diameter more than 1.5mm confirmed by a heart ultrasound scan.
The trial screened 3861 babies with echocardiography born between 23 weeks and less than 29 weeks of pregnancy and included 653 babies who had been diagnosed with a patent ductus arteriosus with a diameter more than 1.5mm and pulsatile flow confirmed by a heart ultrasound scan. Approximately half the babies (326) were randomly assigned to receive ibuprofen and half (327) to receive a placebo. The babies were then assessed when they had reached an age equivalent to 36 weeks of pregnancy to see if they had bronchopulmonary dysplasia, indicating severe damage to the lungs.
- Treatment with ibuprofen within 72 hours of birth was not associated with a reduced risk of death or bronchopulmonary dysplasia when compared with placebo;
- 220 of 318 babies (69.2%) assigned to ibuprofen either died or developed moderate to severe bronchopulmonary dysplasia compared with 202 of 318 babies (63.5%) who were assigned to the placebo;
- Among babies who survived to 36 weeks post-menstrual age, 176 babies (64.2%) assigned to ibuprofen and 169 babies (59.3%) assigned to placebo developed moderate or severe bronchopulmonary dysplasia;
- A single course of ibuprofen given with 72 hours of birth resulted in a closed or insignificant patent ductus arteriosus in 55.5% of babies in the ibuprofen group;
- There was no evidence that treatment with ibuprofen resulted in any additional serious health complications.
Samir Gupta, Professor of Paediatrics and Neonatology at the University of Durham, UK and Sidra Medicine in Doha, Qatar and the trial’s Chief Investigator, said ‘Patent ductus arteriosus is common in extreme premature babies. While the rates of death or moderate or severe bronchopulmonary dysplasia that occurred in participants in the Baby-OSCAR trial are high, these rates are comparable to previous reports. Our results are also consistent with findings from other trials that used ibuprofen as an early intervention and suggest that, while it may reduce the risk of some outcomes, ibuprofen is not an effective treatment for reducing the risk of death or lung disease in extreme premature babies.’
Pollyanna Hardy, Director of the National Perinatal Epidemiology Unit Clinical Trials Unit and joint senior author, said ‘Baby-OSCAR is the largest trial to assess treatment for patent ductus arteriosus in 25 years. The results of the trial provide an important contribution towards the discourse around 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 was funded by the National Institute for Health and Care Research Health Technology Assessment programme and sponsored by the University of Oxford.