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

Jannatdoust 2014.

Study characteristics
Methods Single‐centre randomized controlled trial
Participants Inclusion criteria
  1. GA less than 32 weeks and birth weight 800 g to 1500 g


Exclusion criteria
  1. Congenital abnormalities

  2. severe asphyxia (5‐minute Apgar score < 7 or initial pH < 7.1)

  3. Moderate thrombocytopenia (50,000/μL)

  4. High serum creatinine (1.8 mg/dL)

  5. Obvious bleeding (respiratory, skin, digestive, urinary, mucous)

  6. Antenatal receipt of indomethacin

Interventions Active intervention (n = 35)
IV indomethacin; initial dose 0.2 mg/kg administered between 2 to 12 hours followed by 2 doses of 0.1 mg/kg each at 24 and 48 hours
Control (n = 35)
No placebo
Outcomes Relevant outcomes for this study included
  1. Mortality

  2. IVH

  3. Treatment for symptomatic PDA

Notes Primary study location: Alzahra Educational‐Medical Center, Tabriz, Iran
Study period: June 2010 to December 2012
Trial registration: IRCT201107117010N1
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk computerized randomized number generator used
Allocation concealment (selection bias) Low risk Random allocation determined by Rand List Software
Blinding of participants and personnel (performance bias)
All outcomes High risk No mention of placebo use in control group and no mention of blinding efforts.
Blinding of outcome assessment (detection bias)
All outcomes High risk No mention of placebo use in control group and no mention of blinding efforts.
Incomplete outcome data (attrition bias)
All outcomes Low risk All outcomes reported for all randomized infants.
Selective reporting (reporting bias) Unclear risk Trial was registered retrospectively with the Iranian Registry of Clinical Trials (IRCT201107117010N1).
Other bias Unclear risk Given this was an unblinded study and it was retrospectively registered, difficult to assess if there were other sources of bias.