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

Kanmaz 2013.

Study characteristics
Methods Single‐centre randomized controlled trial
Participants Inclusion criteria
  1. GA less than <2 8 weeks, and/or birth weight < 1000 g.


Exclusion criteria
  1. Major congenital abnormalities

  2. Life‐threatening infection

  3. Grade 3 or 4 IVH

  4. Urine output of < 1mL/Kg/hour during the preceding 8 hours

  5. Serum creatinine of >1.6 mg/dL

  6. Platelet count of < 60000/mm3

  7. Tendency to bleed

  8. Hyperbilirubinaemia requiring exchange transfusion

  9. Persistent pulmonary hypertension

  10. Patients whose early enteral feeding and enteral drug use were inappropriate due to contraindications (such as congenital anomalies, meconium ileus, severe hypotension and asphyxia) were also excluded

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
Outcomes Relevant outcomes for this study included
  1. Mortality

  2. IVH

  3. CLD

  4. NEC

  5. Gastrointestinal perforation

  6. Treatment for symptomatic PDA

  7. Surgical PDA ligation

Notes Primary study location: Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey
Study period: July 2011 and November 2011
Trial registration: NCT01400737
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.