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. 2022 Apr 1;2022(4):CD013846. doi: 10.1002/14651858.CD013846.pub2

Bada 1989.

Study characteristics
Methods Single‐centre randomized controlled trial
Participants Inclusion criteria
  1. Birth weight <1 500 g; periventricular‐intraventricular haemorrhage <grade 1 at 1 hour


Exclusion criteria
  1. Congenital malformations

  2. Thrombocytopenia

  3. Bleeding from puncture site or orifices

  4. Plasma creatinine level > than 1.8mg/dL

Interventions Active intervention (n = 71)
Prophylactic IV indomethacin 0.2 mg/kg at 6 hours of age; and 0.1 mg/kg at 18 hours and 30 hours of age
Control (n = 70)
IV placebo (no description available)
Outcomes Relevant outcomes for this study included
  1. Death before hospital discharge

  2. IVH

  3. CLD (oxygen supplementation beyond 28 days)

  4. NEC (Bell stage 2 or 3 disease)

  5. Oliguria

Notes Primary study location: Regional Medical Center, Memphis, Tenessee, USA
Study period: not specified
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It was not stated how randomization was done
Allocation concealment (selection bias) Unclear risk No information provided on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Placebo was used suggesting personnel were blinded during the study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Primary outcome assessed by one investigator blinded to the allocation
Incomplete outcome data (attrition bias)
All outcomes Low risk All randomized infants accounted for
Selective reporting (reporting bias) Unclear risk No protocol available for comparison
Other bias Unclear risk No specific issues noted.