The significance of Baby-OSCAR trial in determining Prophylactic and early targeted treatment of patent ductus arteriosus
Prophylactic and early targeted treatments have the potential of closing the PDA before it is symptomatic. The prophylactic treatment, once popular, has now become controversial as it unnecessarily exposes a large proportion of preterm babies to the side effects of treatment who would have closed the PDA spontaneously. Persistence of PDA is, however, associated with increase in morbidity and mortality. Early targeted treatment seems promising as it allows selection of babies who are less likely to close the PDA spontaneously and it has the benefits of a prophylactic approach. This approach is currently being tested in large randomized trials awaiting results.
In Baby-OSCAR trial, babies are randomized to receive either the active drug (ibuprofen) used for medical closure of PDA or a matched placebo (normal saline). This aims to answer the clinical question as to whether to treat an asymptomatic ‘significant’ PDA identified in the first 72 h of life. The success of the trial depends on meeting recruitment and retention targets, and, for a fair comparison, open label treatment needs to be kept to a minimum. This has been one of the weaknesses of the trials conducted to date. To minimize this ‘contamination’, the trial protocol sets clinical and echocardiography thresholds that need to be met before considering treatment of a symptomatic PDA. Unlike previous studies, Baby-OSCAR is using a primary outcome of mortality or moderate-to-severe chronic lung disease, plus a number of secondary outcomes including short- and long-term health outcomes at two years of age and health economic evaluation.”
For more information, please read the recently published article by Wyllie and Gupta titled, 'Prophylactic and early targeted treatment of patent ductus arteriosus' in Seminars in Fetal and Neonatal Medicine.