Kanmaz 2013.
Study characteristics | ||
Methods | Single‐centre randomized controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Active intervention (n = 23) Oral ibuprofen,10mg/kg within 12 to 24 hours after birth followed by 5 mg/kg at 24 and 48 hours. Control (n = 23) No placebo |
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Outcomes | Relevant outcomes for this study included
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Notes |
Primary study location: Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey Study period: July 2011 and November 2011 Trial registration: NCT01400737 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation method not specified |
Allocation concealment (selection bias) | Low risk | Patients allocated using sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The control group received no treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Cardiologist blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all enrolled infants |
Selective reporting (reporting bias) | Low risk | All outcomes described in protocol were reported. The trial was registered with ClinicalTrials.gov (NCT01400737). |
Other bias | Unclear risk | Trial was ended prematurely due to high incidence of adverse effects. |