| Methods |
Infants were randomized by a stratified random sampling technique. Allocation concealment is unclear. There was no blinding of the intervention. One author was unblinded to the treatment allocation, but is unclear whether this author was involved in outcome assessments. No power calculations were reported. Early outcome data were reported completely. However, long‐term outcome data included only 15% of the enrolled infants and thus have not been included in this review. |
| Participants |
150 infants with a diagnosis of respiratory distress syndrome or BW <1000g were eligible for inclusion. The numbers excluded prior to randomization are not reported. |
| Interventions |
Experimental group (low PaO2): infants received oxygen only if their PaO2 fell below 40 mmHg or PcapO2 fell below 35 mmHg. Sufficient oxygen was used to maintain these tensions.
Control group (high PaO2): infants were kept in a minimum of 40% oxygen for 72 hours. Aim was to maintain PaO2 80‐120 mmHg or PcapO2 50‐60 mmHg.
Mechanical ventilation was not available to either group. |
| Outcomes |
Mortality (any)
Mortality (respiratory)
Descriptive results of respiratory failure measures were reported (such as retractions, grunting, respiratory pattern and rate, chest Xray changes). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Stratified random sampling technique. |
| Allocation concealment? |
Unclear risk |
Unclear |
| Blinding?
All outcomes |
High risk |
Blinding not stated. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
There was complete follow‐up for early outcomes, but not for late outcomes. Only 15% follow‐up at 10yrs (Coates). |
| Free of selective reporting? |
Low risk |
There were 10 tables and 16 figures of results and analysed data reporting various analyses of the outcome data. It seemed that all outcomes were reported. |
