Skip to main content
. 2022 Apr 1;2022(4):CD013846. doi: 10.1002/14651858.CD013846.pub2

Supapannachart 1999.

Study characteristics
Methods Single‐centre randomized controlled trial
Participants Inclusion criteria
  1. Birth weight < 1250 g

  2. Randomization within first 24 hours

  3. Platelet count >60,000/uL

  4. Plasma creatinine < 2mg/dL & BUN <30 mg/dL

  5. No bleeding diathesis

  6. Urine output during 8 hours prior to randomization >0.5 mL/kg/hour


Exclusion criteria
  1. Major congenital anomalies

  2. Suspicion of NEC

Interventions Active intervention (n = 15)
IV Indomethacin 0.2mg/kg initial dose, followed by two doses of 0.1mg/kg each every 12 hours
Control (n = 15)
IV placebo
Outcomes Relevant outcomes for this study included
  1. Mortality

  2. IVH

  3. Treatment for symptomatic PDA

  4. Surgical PDA ligation

  5. CLD

  6. NEC

Notes Primary study location: Ramathibodi Hospital, Bangkok, Thailand
Study period: 1 April 1994 to 31 May1 1995
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation method unspecified.
Allocation concealment (selection bias) Low risk Sealed envelope technique used.
Blinding of participants and personnel (performance bias)
All outcomes Low risk All personnel were blinded to group, identical placebo was administered to control
Blinding of outcome assessment (detection bias)
All outcomes Low risk All personnel were blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk All randomized infants accounted for.
Selective reporting (reporting bias) Unclear risk Study protocol unavailable. Unclear if any deviations to protocol exist.
Other bias Low risk Appears free of other bias.