BOOST II
ACTRN12605000055606
Treatment
Phase 3
Government body,NHMRC Grant
Prof Prof William Tarnow-Mordi
Oxygen is the commonest neonatal therapy. Unfortunately, both too much and too little oxygen may be harmful for very premature infants. We now measure the oxygen in a baby's blood by oxygen saturation but the optimum range in the first few weeks is unknown and no randomised controlled trial (RCT) has addressed this question. This proposal is for Australian arm of a major international study involving 5000 babies, born at less than 28 weeks, to address this question. Babies will be randomised to .... Read more
a) born <28 weeks gestation b) less than 24 hours of agec) there is informed consent by parent(s) or legal guardian
a) There is a known congenital anomaly that could affect oxygenation or developmentb) attendance for follow-up for 2 years is judged unlikely.
No
Sample Size 1135
Min. age 0 Days
Max. age 1 Days
Sex Both males and females
Condition category Preterm infants
Condition code Reproductive Health and Childbirth
Intervention code None
Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)
Control group Dose comparison
This is a comparison study and aims to compare the two ranges within the normal clinical practice of 85-95% oxygen saturations. At the moment neither the Lower (85-89%) nor the Higher Oxygen Saturations (91-95%) is seen as the standard, and the purpose of the study is to compare both against each other in order to determine the ideal target within that range.
Outcome: Prior to unblinding the data for analysis, a Statistical Analysis Plan was produced and signed off by Prof Tarnow-Mordi, Dr Adrienne Kirby and Prof Val Gebski on 10th February, 2014. A specific process for determining the primary outcome of death or disability was included, as follows (Section 5.5.) Infants will be classified as having had the primary endpoint if (a) they have died prior to 2 years corrected gestational age; or (b) assessment at 2 years corrected ges .... Read more