Ment 1988.
| Methods | Blinding of randomisation: yes Blinding of intervention: yes Blinding of outcome measurement: yes Complete (> 90%) follow‐up: yes | |
| Participants | 36 newborn infants, birthweight < 1250 grams. Excluded infant with IVH on pre‐study ultrasound examination. |
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| Interventions | Indomethacin versus saline placebo. Indomethacin dosage: 3 doses (3 x 0.1 mg/kg), first dose 6 ‐ 12 hours of age, 24 hourly thereafter. Study medication stopped if IVH detected, abnormal bleeding, thrombocytopaenia, elevated plasma urea, or urine output <0.5 ml/kg/hr. | |
| Outcomes | Death IVH PDA Renal function (electrolyte abnormality, urine output) Haemostasis (Platelet count, clinical bleeding) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Adequate |
| Allocation concealment? | Low risk | Adequate |
| Blinding? All outcomes | Low risk | Blinding of intervention ‐ yes Blinding of outcome measurement(s) ‐ yes |
| Incomplete outcome data addressed? All outcomes | Low risk | Complete (> 90%) follow‐up: yes |