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Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544972
First Posted: March 6, 2012
Last Update Posted: December 17, 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):
Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital
  Purpose
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels 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: Diagnostic
Official Title: Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen

Resource links provided by NLM:


Further study details as provided by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA [ Time Frame: up to 6 months ]

    The measurement of Serum levels of Paracetamol and Ibuprofen in preterm infants treated with Oral Paracetamol and Oral Ibuprofen.

    To determine of effective serum levels of paracetamol and ibuprofen for treatment of patent ductus arteriosus in preterm infants.

    In normally, effective and safely dose of NSAIDs for treatment of PDA are exactly unknown. Therefore we will detected cut-off serum levels for effective, safely and hazardous.



Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 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 for 3 days
Drug: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
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 oral paracetamol and ibuprofen efficacy and safety in relation to serum levels 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 for 3 days.

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.

Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained.

The relation of pharmacokinetics of drugs to drug response will be evaluated

  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
  • Severe thrombocytopenia < 60.000
  • 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): NCT01544972


Contacts
Contact: Sadık Yurttutan, MD sdkyurttutan@gmail.com
Contact: Mehmet Yekta Oncel, MD dryekta@gmail.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Recruiting
Ankara, Turkey
Contact: Ugur Dilmen, Professor       ugurdilmen@gmail.com   
Contact: Omer Erdeve, As.Prof       omererdeve@yahoo.com   
Principal Investigator: Sadık Yurttutan, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: Sadık Yurttutan, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01544972     History of Changes
Other Study ID Numbers: ZTB170212
First Submitted: February 22, 2012
First Posted: March 6, 2012
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital:
Patent Ductus Arteriosus
Paracetamol
Ibuprofen
Serum levels
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