| Methods |
Randomised controlled trial‐double blind.
Blinding or randomization ‐ yes. Random number sequence with master code in sealed envelope. Blinding of intervention achieved with identical vials of treatment and placebo. Outcome data available for all enrolled subjects. Methods of blinding of outcome assessment not clearly defined. |
| Participants |
35 newborn infants with meconium staining of the skin and positive tracheal aspiration of meconium who had one of two criteria: 1: clinical signs of respiratory distress in the first 4 hours and/or 2: radiographic findings of aspiration syndrome. |
| Interventions |
Intervention group n=17; Control group n=18.
Identical vials of hydrocortisone or placebo (lactose hydrous) in similar diluent administered at same intervals. Hydrocortisone 20mg/kg initially then q12h for 4 doses given immediately after diagnosis. |
| Outcomes |
Need for mechanical ventilation, incidence of air leak, mortality, alveolar‐arterial oxygen gradient, duration of oxygen therapy, length of respiratory distress. |
| Notes |
Study conducted between October 1974 and September 1975 in hospital setting in Illinois, USA. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
