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

Intervention

Intervention code None

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

Comparison

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.

Outcomes

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 .... 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 gestational age shows major disability. If an infant’s survival status at 2 years is unknown, or they are known to be alive but information on major disability is not available, their primary outcome will be missing. The classification of infants as having a major disability is determined from: * Bayley III Developmental Assessment completed by a blinded psychologist; or in some cases Bayley II Developmental Assessment * Health Status assessment completed by a blinded paediatrician; or in some cases a Short Health Status Questionnaire collected mainly via phone call to parents or a GP visit if this is not available An infant will be classified as having major disability if they are alive at 2 years corrected gestational age and meet at least one of the following criteria: * Cerebral palsy with GMFCS level >= 2, as indicated on the health status (Q29) or short health status (Q1) assessments * Legal blindness, as indicated on the on the health status (Q7) or short health status (Q2) assessments * Hearing loss requiring hearing aids, as indicated on the health status (Q11) or short health status (Q3) assessments * Composite cognitive score < 85 or composite language score < 85 on the Bayley III assessment; or cognition Mental Development Index (MDI) < 70 on the Bayley II assessment If cognitive disability cannot be determined because the relevant Bayley III or Bayley II items are missing, the final criterion above can be replaced by any one of the following from the health status assessment: * Uses less than 10 words (Q13); or language problems indicated on the short health assessment (Q4) * Delayed development by more than 12 months (Q32) * Other severe impairment (Q34) If the infant does not meet any of the first three criteria, and all information on the Bayley assessment and these substitute criteria is also missing, the infant’s primary endpoint status will be missing.
Timepoint: At 2 years old corrected for gestation at birth.
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