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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01536158
First received: February 15, 2012
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Patent Ductus Arteriosus
Drug: Oral paracetamol
Drug: Oral ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Oral Paracetamol Versus Oral Ibuprofen Treatment

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen [ Time Frame: Until discharge ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: corrected 36 weeks or until discharge ] [ Designated as safety issue: Yes ]
    Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.


Enrollment: 80
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
Drug: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Other Name: Calpol
Active Comparator: 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.
Drug: 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 Name: Pedifen

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

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536158

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, Turkey, 06110
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: Mehmet Yekta Oncel, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Additional Information:
No publications provided by Zekai Tahir Burak Women's Health Research and Education Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01536158     History of Changes
Other Study ID Numbers: ZTB150212
Study First Received: February 15, 2012
Last Updated: December 24, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
Patent Ductus Arteriosus
Paracetamol
Ibuprofen
Preterm infant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014