BOOST-II UK trial - targeting oxygen saturation levels in preterm babies
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.
- Stenson B, Brocklehurst P, Tarnow-Mordi W. Increased 36-Week Survival with High Oxygen Saturation Target in Extremely Preterm Infants. N Engl J Med. 2011;364(17):1680-2.
- Johnston ED, Boyle B, Juszczak E, King A, Brocklehurst P, Stenson BJ. Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeter. Arch Dis Child Fetal Neonatal Ed. 2011;96(6):F429-F33.
- Askie LM, Brocklehurst P, Darlow BA, Finer N, Schmidt B, Tarnow-Mordi W, Ne OCG. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatr. 2011;11:6.
- BOOST II United Kingdom Collaborative Group, BOOST II Australia Collaborative Group, BOOST II New Zealand Collaborative Group, Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013;368(22):2094-104.
- Australia TB-I, Groups UKC. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016;374(8):749-60.
- Moreton RB, Fleck BW, Fielder AR, Williams CA, Butler L, Wilson C, Cocker K, Juszczak E, King A, Stenson B, Brocklehurst P. The effect of oxygen saturation targeting on retinal blood vessel growth using retinal image data from the BOOST-II UK Trial. Eye (Lond). 2016;30(4):577-81.
- Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, J. MC, Doyle LW, Gebski V, Hunter KE, Simes RJ, Collaboration ftNOPM-aN. Association between oxygen saturation targeting and death or disability in extremely preterm infants in the neonatal oxygenation prospective meta-analysis collaboration. JAMA. 2018;319(21):2190-201.
- Stenson BJ, Donoghoe M, Brocklehurst P, Davis PG, Juszczak E, Marschner IC, Simes J, Tarnow-Mordi WO. Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. The Journal of Pediatrics. 2018;204:301-4.e2.