Benefits Of Oxygen Saturation Targeting Study (BOOST-II) dataset

The University of Sydney

Dataset description

This dataset includes 1135 participants receiving either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range in 15 centres in Australia. Baseline data will include demographics, antenatal glucocorticoid treatment, method of delivery and temperature at admission to the neonatal unit. Clinical outcomes will include survival or disability status, language or cognitive score (based on the Bayley III Developmental Assessment) as well as health status including cerebral palsy with GMFCS ≥2, severe visual loss and severe hearing loss (based on the Health Status Assessment or Short Health Status Questionnaire) at corrected age of 2 years.
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Neonatal health |

Source Study

Trial acronym


Trial ID





Phase 3


Government body,NHMRC Grant

Scientific enquiries

Prof Prof William Tarnow-Mordi

Brief Summary

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 ....
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Key Inclusion Criteria

a) born <28 weeks gestation b) less than 24 hours of agec) there is informed consent by parent(s) or legal guardian

Key Exclusion Criteria

a) There is a known congenital anomaly that could affect oxygenation or developmentb) attendance for follow-up for 2 years is judged unlikely.

Can healthy volunteers participate?




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 ....
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The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see