| Methods |
Adequate randomisation: yes, computer used.
Allocation concealment: yes.
Blinding of intervention: no.
Blinding of measurement: no.
Losses to follow‐up: none. |
| Participants |
Infants < 34 weeks, birthweight < 2000g, mechanically ventilated for RDS, hypotension (MAP < 25, 30, 35 mmHg at < 1kg, 1‐1.49 kg, 1.5‐1.99 kg respectively) at < 2 hours age, no previous fluids or inotropes.
Exclusions: infants of mothers given antihypertensives within 24 hours of birth, severe congenital anomalies, cyanotic heart disease or left ventricular outflow anomalies
Mean gestation: Intervention group: 28.1 weeks (sd 4.0); Control: 28.5 weeks (sd 2.8).
Mean birthweight: Intervention: 1123g (sd 458); Control: 1163g (sd 367). |
| Interventions |
Intervention (n = 32): 5% albumin 10 ml/kg over 30 mins up to 3 doses.
Control (n = 31): isotonic saline 10 ml/kg over 30 mins up to 3 doses. |
| Outcomes |
Stated primary outcome: treatment failure (persistent hypotension requiring dopamine).
Other outcomes: need for extra volume, weight gain, urine output, serum sodium, patent ductus (echo confirmed), P/IVH (ultrasound at 2 and 6 days and 3 weeks), necrotising enterocolitis, chronic lung disease (oxygen at 28 days and 36 weeks post conception), and mortality. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
