Methods |
Randomised controlled trial ‐ factorial design |
Participants |
42 preterm infants, entry at 96 hours if gestation < 32 weeks, mechanical ventilation from birth, surfactant treatment, and high risk of developing BPD based on score (Ryan 1996)
Exclusion criteria: major congenital anomaly, structural cardiac defect, significant ductus shunting, culture‐positive sepsis, IVH with parenchymal involvement, pulmonary or GI haemorrhage, abnormal coagulation, thrombocytopenia (platelets < 50,000) |
Interventions |
Intravenous dexamethasone at 12‐hourly intervals for 6 days; 0.5 mg/kg/dose for 6 doses and 0.25 mg/kg/dose for a further 6 doses. Inhaled NO 5 to 20 ppm for 72 hours
Control groups were not given placebo |
Outcomes |
Mortality, BPD at 28 days and > 36 weeks with abnormal chest radiograph
Duration of ventilation, time to extubation, duration of hospitalisation, maximum grade of IVH, pulmonary haemorrhage, pneumothorax, severe PDA, NEC, ROP (stage 3 or 4)
Complications including ileal perforation, upper GI haemorrhage, hyperglycaemia, hypertension, septicaemia |
Notes |
Note factorial design, which means that half of treated infants and half of control infants also received 72 hours of inhaled NO |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random allocation by computer‐generated random numbers and sealed envelopes. Factorial design provided 4 groups: early dexamethasone, inhaled NO, both drugs together, and neither drug. |
Allocation concealment (selection bias) |
Low risk |
Allocation concealment: yes |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding of intervention: no |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Blinding of outcome measurements: no |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes |
Selective reporting (reporting bias) |
Unclear risk |
All prespecified outcomes reported |