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 <1750g birth weight ventilated with UAC in situ. Documented PDA on contrast echocardiogram, without clinical symptoms of left to right shunt
indomethacin n=13
placebo n=14 |
Interventions |
Indomethacin or placebo 0.3mg/kg repeated at 24, 48 & 72 hours if echo remains positive |
Outcomes |
Mortality,Chronic lung disease, IVH, ROP, Symptomatic PDA, PDA ligation, Length of ventilation, Length of hospital stay, Days of supplemental oxygen |
Notes |
1 post randomisation exclusion |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |