Baby-OSCAR Trial

• Research type

  Research Study

• Full title

  Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies

• IRAS ID

  142310

• Contact name

  Samir Gupta

• Contact email

  samir.gupta@durham.ac.uk

• Eudract number

  2013-005336-23

• ISRCTN Number

  ISRCTN84264977

• Research summary

  Summary of Research
  The ductus arteriosus is a tube that bypasses blood from the lungs to placenta while the baby is in womb. In babies born extremely premature the ductus arteriosus often fails to close spontaneously as it does normally in babies who are born near term, and this is called a Patent Ductus Arteriosus (PDA) and results in extra blood entering the lungs which places the baby at higher risk of death and complications of prematurity.

  Various treatment strategies to close PDA have failed to report any improvement in health outcomes. Additionally, prophylactic treatment exposes over half of babies to the side effects of treatment who would have otherwise closed PDA spontaneously. The proposed study uses an approach of selecting babies with a large PDA before they are symptomatic using heart ultrasound (echocardiography) that overcomes the limitations of current treatment practices. This trial was conducted at 32 neonatal intensive care units across the United Kingdom. We compared the two study groups (intervention using parenteral ibuprofen and matched placebo) and studied the outcome in babies who die or need oxygen / breathing support when they are the equivalent of 36 weeks of gestation. We also compared rates of other complications of prematurity. We followed these babies up to 2 years of age to assess their health and development and the cost-effectiveness of the two approaches over this period.

  The study recruited 653 babies out of a sample size of 730. The short term outcomes until 36 weeks of corrected age for prematurity found no evidence of reduction in risk of death or moderate or severe bronchopulmonary dysplasia (dependence on oxygen or respiratory support at 36 weeks post menstrual age). Additionally, there was no evidence of an improvement in health or developmental problems
  

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  14/EM/0172

• Date of REC Opinion

  23 May 2014

• REC opinion

  Favourable Opinion