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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536158
First Posted: February 20, 2012
Last Update Posted: December 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Paracetamol Versus Oral Ibuprofen Treatment

Resource links provided by NLM:


Further study details as provided by Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen [ Time Frame: Until discharge ]
    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 ]
    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

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 15, 2012
First Posted: February 20, 2012
Last Update Posted: December 27, 2012
Last Verified: December 2012

Keywords provided by Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching 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
Ibuprofen
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics