| Methods |
Double‐blind randomised controlled trial |
| Participants |
48 infants of gestation < 32 weeks and birth weight < 1500 grams who had systemic hypotension despite treatment with volume expanders and dopamine within the first 7 days of life Infants also had to have an indwelling arterial catheter for continuous BP monitoring.
Exclusions: major or lethal congenital or chromosomal abnormalities, congenital heart defects, previous postnatal systemic or inhaled corticosteroids, proven infection, NEC |
| Interventions |
Hydrocortisone 1 mg/kg every 8 hours for 5 days
Control infants received isotonic saline as placebo for 5 days. |
| Outcomes |
BP, use of vasopressors, duration of ventilation, oxygen and hospital stay, PIE, pulmonary haemorrhage, pneumothorax, hyperglycaemia, glycosuria, IVH (grade III or IV), PVL, NEC, GI perforation, sepsis, ROP (> stage II), mortality |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random allocation in blocks of 6 by computer‐generated random numbers and opening numbered, sealed, opaque envelopes |
| 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 |
Primary outcome was blood pressure, which was reported. |
