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Baby-OSCAR is approaching the 300th baby milestone!

Who will be the lucky team to hit this target?

We now have 31 actively recruiting sites across the UK and have so far recruited 13 babies in 8 days in September! What an achievement.

Keep up the great work and thank you all for your ongoing support of the study.

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. 

All planned 32 centres are open to recruitment across the UK

We are thrilled to welcome on board our last recruiting site Royal Maternity Hospital, Belfast, who opened to recruitment on 9th May 2018. Baby-OSCAR is now recruiting in all parts of the UK including Northern Ireland and we continue to set up continuing care sites to ensure primary outcomes are collected at 36 weeks. We wish everyone happy screening and recruiting.

Double century for Baby-OSCAR

Baby-OSCAR surpassed 200 recruits on 21st April 2018. Special congratulations to the team at Bradford Royal Infirmary for recruiting a pair of twins to bring up the milestone. The trial team would like to thank all recruiting teams across the UK for their hard work in making this milestone possible.

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This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Reference Number 11/92/15). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.