| Methods |
Adequate randomisation: yes, random number generator, blocks of 10, using sealed envelopes
Allocation concealment: yes
Blinding of intervention: no
Blinding of measurement: no
Losses to follow up: none |
| Participants |
Preterm infants < 1501 g and < 24 hours age, indwelling arterial line, hypotensive (mean BP < 10th percentile), given 20 mls/kg plasma protein fraction prior to insertion of line if clinician felt infant to be 'shocked'
Mean gestation: Group 1: 26.5 weeks (range 604‐1452); Group 2: 27 (23‐31)
Mean birthweight: Group 1: 980g (range 640‐1300); Group 2: 990g (660‐1450) |
| Interventions |
Group 1 (n = 20): albumin 4.5% 20 mls/kg over 30 mins, repeated if mean BP not increased to > 10th percentile
Group 2 (n = 19): dopamine 5 mcg/kg/min, increased by 2.5 mcg/kg/min every 30 mins up to maximum 10 mcg/kg/min or mean BP > 10th percentile |
| Outcomes |
Stated primary outcome: correction of hypotension (mean BP < 10th percentile)
Other outcomes: peri/intraventricular haemorrhage, duration of ventilation, chronic lung disease (oxygen at 28 days with abnormal chest x‐ray), retinopathy of prematurity, mortality |
| Notes |
49% of infants received volume expansion prior to study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
