Methods |
Double blind RCT of indomethacin vs placebo for infants with asymptomatic PDA
Blinding of randomisation: Yes
Blinding of intervention: Yes
Complete follow up: No
Blinding of outcome assessment: can't tell |
Participants |
Infants <1000g birth weight with contrast echocardiogram evidence of PDA with left to right shunt at day 3 of life, in the absence of symptoms of left to right shunt. Excluded if congenital cyanotic heart disease, PPHN, or no UAC
indomethacin n= 11
placebo n= 15 |
Interventions |
Indomethacin or placebo 0.2mg/kg for 3 doses, 12 hours apart |
Outcomes |
Chronic Lung disease, Symptomatic PDA, Treated PDA, Length of ventilation, Days of supplemental oxygen |
Notes |
2 post randomisation exclusions |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |