| Methods |
Single centre.
Adequate randomisation: yes, performed by a pharmacist using computer code generated after obtaining consent.
Allocation concealment: yes.
Blinding of intervention: yes, fluid was sent to the NICU in syringe concealed by an opaque wrapper.
Blinding of measurement: yes.
Losses to follow‐up: unclear. Abstract reported 53 infants in normal saline group, publication 52 infants. |
| Participants |
Infants admitted to NICU <24 hours age, ≦ 3 days age, mean arterial pressure <5th percentile by Versmold criteria for >10 minutes and parental permission.
Infants mean gestational age (weeks) albumin group: 30.8±4.4; normal saline: 30.1±4.1. Mean birth weight (g): albumin: 1617±838; normal saline: 1528±830. |
| Interventions |
5% albumin 10ml/kg infused over 20 minutes (n = 49).
Normal saline 10ml/kg infused over 20 minutes (n = 53).
Volume repeated if failure of response.
Treatment success defined as resolution of hypotension after 2 boluses ‐ infants received dopamine. |
| Outcomes |
Primary outcomes: improvement in arterial BP to normal (greater than the 10th percentile for mean BP for weight) at 1 hour after infusion.
Other outcomes: urine output, use of second bolus of volume, use of pressure support, average cost of treatment, average amount of nursing time required for preparation of drug. Treatment failure defined as need for pressor support for persisting hypotension (mean BP<5th percentile). Reported PIVH for infants <1500g only. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
