Garland 1999.
Study characteristics | ||
Methods | Multi‐centre placebo‐controlled randomised trial | |
Participants | 241 infants weighing between 500 grams and 1500 grams, who received surfactant, at significant risk for BPD or mortality based on a model used to predict at 24 hours | |
Interventions | 3‐day course of dexamethasone beginning at 24 to 48 hours. First 2 doses were 0.4 mg/kg, third and fourth doses 0.2 mg/kg, and fifth and sixth doses 0.1 mg/kg and 0.05 mg/kg, respectively. Dexamethasone dose was reduced slightly after first interim analysis (see Notes) Similar volume of normal saline was given to control infants | |
Outcomes |
Primary outcomes
Secondary outcomes
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Notes | At first interim analysis (n = 75), increased risk of GI perforation was noted in the dexamethasone group. Data Monitoring Committee recommended reducing the dexamethasone dose to 4 doses of 0.25 mg/kg/dose every 12 hours begun at 24 to 48 hours, followed by doses of 0.125 mg/kg and 0.05 mg/kg at the next two 12‐hour periods, respectively | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by study pharmacists at each centre |
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 measurements: 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 |