Watterberg 1999.
Study characteristics | ||
Methods | Two‐centre double‐blind randomised controlled trial | |
Participants | Inclusion: 40 infants weighing between 500 grams and 999 grams who were AGA and needed mechanical ventilation, < 48 hours of age Exclusions: maternal diabetes, congenital sepsis, SGA | |
Interventions | Hydrocortisone 1.0 mg/kg/d every 12 hours for 9 days, 0.5 mg/kg/d for 3 days Control infants were given an equal volume of normal saline | |
Outcomes |
Primary outcome
Secondary outcomes among survivors
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation at each centre by constant block design with 4 participants per block to minimise bias over time. Separate randomisation tables were used for infants exposed to antenatal corticosteroids |
Allocation concealment (selection bias) | Low risk | Allocation concealment: yes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of intervention: yes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome measurement: yes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up: yes |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Low risk | None |