Clinical trial NCT01536158: Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
Official title: Oral Paracetamol Versus Oral Ibuprofen Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patent Ductus Arteriosus
Keywords: Patent Ductus Arteriosus
Paracetamol
Ibuprofen
Preterm infant
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Detailed description: To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

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.

Eligibility criteria: Inclusion Criteria:

* Birth weight below 1250 gram
* Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* 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

Primary outcomes:
measure: Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
timeFrame: Until discharge
Secondary outcomes:
measure: Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
timeFrame: corrected 36 weeks or until discharge
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Mehmet Yekta Oncel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.