Doyle 2006.
| Methods | Multi‐centre double‐blind randomised controlled trial | |
| Participants | 70 infants < 28 weeks' gestation or < 1000 grams birth weight, ventilator‐dependent after 7 days Exclusions: congenital neurological defects, chromosomal anomalies, other disorders likely to cause long‐term neurological deficits | |
| Interventions | A 10‐day tapering course of dexamethasone (0.15 mg/kg/d for 3 days, 0.10 mg/kg/d for 3 days, 0.05 mg/kg/d for 2 days, and 0.02 mg/kg/d for 2 days). Total dose of dexamethasone 0.89 mg/kg over 10 days Control infants were given equivalent volumes of normal saline placebo. A repeat course of the same blinded drug was allowed at the discretion of attending clinicians. | |
| Outcomes | Ventilator settings, oxygen requirements, hyperglycaemia, hypertension, growth, BPD (any oxygen at 36 weeks), severe BPD (> 30% oxygen at 36 weeks' PMA), mortality, infection, NEC, GI bleeding, PDA, ROP, cardiac hypertrophy, cranial ultrasound abnormalities Long‐term follow‐up at 2 years of age by staff blinded to treatment allocation for neurological impairments and disabilities, including cerebral palsy |
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| Notes | Sample size estimate was 814, but study was stopped early because of slow recruitment. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random allocation was computer‐generated centrally, independent of investigators, except the statistician, and was stratified by centre, with randomly permuted blocks of 2 to 8 infants. |
| Allocation concealment (selection bias) | Low risk | Blinding of randomisation: yes |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Blinding of intervention: 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) | Unclear risk | All prespecified outcomes reported |