Walther 2003.
| Methods | Double‐blind randomised controlled trial | |
| Participants | 36 infants of gestation 24 to 32 weeks and birth weight > 599 grams with respiratory distress syndrome requiring mechanical ventilation with > 29% oxygen or respiratory index (MAP x inspired oxygen) > 1.9 and ventilator rate > 16/min on days 7 to 14 after birth Exclusions: sepsis, congenital heart disease, hypertension, unstable clinical status (renal failure, grade IV IVH), multiple congenital anomalies | |
| Interventions | 14‐Day course of dexamethasone (0.20 mg/kg/d for 4 days, 0.15 mg/kg/d for 4 days, 0.10 mg/kg/d for 4 days, and 0.05 mg/kg/d for 2 days). Total dose of dexamethasone 1.9 mg/kg over 14 days Control infants received equivalent amounts of normal saline placebo | |
| Outcomes | Ventilator settings, MAP, inspired oxygen concentration, extubation within 7 to 14 days, hyperglycaemia, hypertension, serum cortisol, received late dexamethasone, BPD (oxygen at 36 weeks' PMA), survival without BPD | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random allocation by staff pharmacist, with investigators and clinicians unaware of treatment assignment |
| Allocation concealment (selection bias) | Low risk | Allocation concealment: 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 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 |
BPD: bronchopulmonary dysplasia. CLD: chronic lung disease. CP: cerebral palsy. CXR: chest x‐ray. FiO2: fraction of inspired oxygen. GI: gastrointestinal. HIV: human immunodeficiency virus. IPPV: intermittent positive‐pressure ventilation. IVH: intraventricular haemorrhage. IV: intravenous. MAP: mean airway pressure. MDI: Mental Developmental Index. MRI: magnetic resonance imaging. NEC: necrotising enterocolitis. PDA: patent ductus arteriosus. PDI: Psychomotor Developmental Index. PMA: postmenstrual age. ROP: retinopathy of prematurity.