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BOOST-II UK trial - targeting oxygen saturation levels in preterm babies

Principal investigator
Peter Brocklehurst (NPEU)
Collaborators
Stephen Wardle (Nottingham University Hospitals NHS Trust, Nottingham, UK), Win Tin (University of Newcastle), Ben Stenson (Simpson Memorial Maternity Pavilion, Edinburgh), Neil Marlow (University College London), Edmund Hey (deceased) (University of Newcastle), Henry Halliday (Queen's University of Belfast), Sanjeev Deshpande (Royal Shrewsbury Hospital, Shrewsbury), Pamela Cairns (University of Bristol)
Topics
Care of the preterm or low birthweight infant, Preterm birth
Funder
Medical Research Council
Start year
2006
End year
2013
NPEU Contact
Ed Juszczak

Summary

It is not known whether very preterm babies should be given enough oxygen to maintain arterial saturation a little above what it is in utero, or enough to achieve the saturations seen in the healthy term baby after birth. Observational studies suggest that rates of retinopathy of prematurity correlate with differing attitudes towards early oxygen use. However restricting oxygen exposure to minimise this problem risks increasing early mortality, the number of survivors with cerebral palsy, and cognitive ability in the long term survivors.

This double blind randomised controlled trial compared the effects of maintaining functional arterial oxygen saturations at levels of 85-89% versus 91-95% in babies born at less than 28 weeks of gestation. The primary outcome for the trial was mortality and major disability at age 2 years. Secondary outcomes included retinal surgery for retinopathy of prematurity as well as duration of oxygen therapy, chronic lung disease, growth and health service utilisation. The target sample size for the trial was 1,200 babies from approximately 20 UK centres over a period of four years, starting in 2008.

Please note that recruitment was stopped on 24/12/2010 due to safety concerns by the respective independent Trial Steering Committees in the UK and Australia/New Zealand.

Now that the main trial results have been published, the data from BOOST-II UK will be entered into a prospective ipd meta-analysis, co-ordinated by Dr Lisa Askie in Australia, on behalf of the NeOProM collaboration.

Publications

Journal Articles