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

BackgroundThe question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29weeks' gestation are born in the UK every year. In 40% of cases the PDA will fail to close spontaneously, even by 4months of age. Untreated PDA can be associated with several serious and life-threatening short and long-term complications. Reliable data to support clinical decisions about PDA treatment are needed to prevent serious complications in high risk babies, while minimising undue exposure of infants. With the availability of routine bedside echocardiography, babies with a large PDA can be diagnosed before they become symptomatic.MethodsThis is a multicentre, masked, randomised, placebo-controlled parallel group trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies (23(+0)-28(+6) weeks' gestation) improves short and long-term health and economic outcomes. With parental informed consent, extremely preterm babies (born between 23(+0)-28(+6) weeks' gestation) admitted to tertiary neonatal units are screened using echocardiography. Babies with a large PDA on echocardiography, defined by diameter of at least 1.5mm and unrestricted pulsatile PDA flow pattern, are randomly allocated to either ibuprofen or placebo within 72h of birth. The primary endpoint is the composite outcome of death by 36weeks' postmenstrual age or moderate or severe bronchopulmonary dysplasia (BPD) at 36weeks postmenstrual age.DiscussionProphylactic pharmacological treatment of all preterm babies unnecessarily exposes them to potentially serious side effects of drug treatment, when their PDA may have closed spontaneously. However, delaying treatment until babies become symptomatic could result in loss of treatment benefit as irreversible damage may have already been done.Targeted, early pharmacological treatment of PDA in asymptomatic babies has the potential to overcome the disadvantages of both prophylactic (overtreatment) and symptomatic approaches (potentially too late). This could result in improvements in the clinically important short-term clinical (mortality and moderate or severe BPD at 36weeks' postmenstrual age) and long-term health outcomes (moderate or severe neurodevelopment disability and respiratory morbidity) measured at 2years corrected age.Trial registrationISRCTN84264977. Date assigned: 15/09/2010.

Automated summary

The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear is still a focus of neonatal medicine research. This study aims to investigate the effects of using ibuprofen to treat PDA in extremely preterm babies. Early targeted treatment of PDA may improve short and long-term health and economic outcomes.