None listed
Conditions
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 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.
Interventions
Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)
Sponsors
NHMRC Clinical Trials Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 1 Days
Healthy volunteers
No
Inclusion criteria
a) born <28 weeks gestation b) less than 24 hours of agec) there is informed consent by parent(s) or legal guardian
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.
Outcome results
None listed