| Methods |
Randomized to one of 4 treatment groups, using sealed envelopes and thus allocation concealment was adequate. There was no blinding of treatment intervention, and it is unclear whether there was blinding of outcome assessments. No power calculations were reported. Short‐term follow up was complete. |
| Participants |
20 infants with BW 1000‐2500g less than 24 hours age who were hypoxic and acidemic were included. |
| Interventions |
Infants were randomized to one of four treatment groups including combinations of the following treatments: restricted vs. liberal ambient oxygen, rapid vs. slow alkali infusion, assisted vs. spontaneous ventilation. There was random allocation of the other two treatments within the two oxygen therapy groups, hence the data from this trial were included in the review.
Experimental group (restricted oxygen): supplemental oxygen, to a maximum of 35%, to keep PaO2 50‐120 mmHg. If PaO2 fell below 40 mmHg or infant became bradycardic, could give unlimited oxygen and would be considered as a treatment failure.
Control group (liberal oxygen): received 100% headbox oxygen for first 2 hours, then aimed to maintain PaO2 at 50‐120 mmHg using any FiO2 needed. |
| Outcomes |
Mortality (any)
Physiological measures including:
‐ acid‐base balance
‐ PaO2 levels
‐ percentage right‐left shunt
‐ serum electrolytes, blood urea nitrogen, serum lactate
‐ urinary net acid excretion
‐ plasma bicarbonate
‐ "apparent" bicarbonate space
Long‐term neurological assessments reported as "in progress" in the paper were never completed (personal communication J. Sinclair, July 1998). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Sealed envelopes & stratified |
| Allocation concealment? |
Low risk |
Random allocation to 1 of 4 treatment groups, using sealed envelopes; stratified by severity of A (severe vs. moderate). |
| Blinding?
All outcomes |
High risk |
Blinding not stated. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
There was complete follow‐up (but not specified). Short‐term follow‐up was complete. |
| Free of selective reporting? |
Low risk |
There were 14 tables and 15 figures of results and analysed data reporting various analyses of the outcome data. It seemed all outcomes were reported. |
