TerminatedPhase 3ACTRN12605000055606

BOOST II: Benefits Of Oxygen Saturation Targeting Study

Which oxygen saturation level should we use for very premature infants? A randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants


Sponsor

NHMRC Clinical Trials Centre

Enrollment

1,200 participants

Start Date

Mar 25, 2006

Study Type

Interventional

Conditions

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 a higher or lower target range of oxygen saturation from birth (85-89% or 91-95%). For all oximeters staff will target a masked range of 88-92%. We will assess which of the two target ranges is associated with the best overall outcome, which is a composite measure of survival, disability on a standard test of neurodevelopment (Bayley scales), and visual function at 2 years of age.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 1 Days

Plain Language Summary

Simplified for easier understanding

The BOOST II study tests different target ranges for blood oxygen levels in extremely premature babies to find the safest levels. It is for babies born before 28 weeks of pregnancy who are less than 24 hours old. Parents provide consent for their baby's participation in oxygen level monitoring.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)

Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)


Locations(1)

Taiwan, Province Of China

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