Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
NCT ID: NCT01536158
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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Detailed Description
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Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.
One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Oral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Oral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Interventions
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Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Oral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion Criteria
* Urine output of less than 1 ml/kg/h during the preceding 8 h,
* Serum creatinine level \>1.6 mg/dl,
* Platelet count \<60,000/mm3,
* Liver failure,
* Hyperbilirubinemia requiring exchange transfusion
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis
2 Days
10 Days
ALL
No
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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Mehmet Yekta
Zekai Tahir Burak Maternity and Teaching Hospital
Principal Investigators
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Mehmet Yekta Oncel, MD
Role: PRINCIPAL_INVESTIGATOR
Zekai Tahir Burak Women's Health Research and Education Hospital
Locations
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Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, , Turkey (Türkiye)
Countries
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References
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Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5.
Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10.
Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
Related Links
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Other Identifiers
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ZTB150212
Identifier Type: -
Identifier Source: org_study_id