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Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

Primary Purpose

Patent Ductus Arteriosus

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Oral paracetamol
Oral ibuprofen
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant

Eligibility Criteria

2 Days - 10 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral paracetamol

Oral ibuprofen

Arm Description

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Outcomes

Primary Outcome Measures

Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment

Secondary Outcome Measures

Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.

Full Information

First Posted
February 15, 2012
Last Updated
December 24, 2012
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01536158
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral paracetamol
Arm Type
Active Comparator
Arm Description
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
Arm Title
Oral ibuprofen
Arm Type
Active Comparator
Arm Description
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Intervention Type
Drug
Intervention Name(s)
Oral paracetamol
Other Intervention Name(s)
Calpol
Intervention Description
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Intervention Type
Drug
Intervention Name(s)
Oral ibuprofen
Other Intervention Name(s)
Pedifen
Intervention Description
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Primary Outcome Measure Information:
Title
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
Description
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
Time Frame
Until discharge
Secondary Outcome Measure Information:
Title
Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
Description
Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.
Time Frame
corrected 36 weeks or until discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Yekta Oncel, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
28395364
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.
Results Reference
derived
PubMed Identifier
24359938
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.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0015687271&QV1=IBUPROFEN
Description
Ibuprofen
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000103902&QV1=PARACETAMOL
Description
Paracetamol

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Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

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