Jannatdoust 2014.
Study characteristics | ||
Methods | Single‐centre randomized controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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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 |
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Outcomes | Relevant outcomes for this study included
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Notes |
Primary study location: Alzahra Educational‐Medical Center, Tabriz, Iran Study period: June 2010 to December 2012 Trial registration: IRCT201107117010N1 |
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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. |