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

Primary Purpose

Patent Ductus Arteriosus

Status
Unknown status
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 diagnostic trial for Patent Ductus Arteriosus focused on measuring Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Serum levels, 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
  • Severe thrombocytopenia < 60.000
  • Severe intracranial bleeding (Grade III - IV)
  • Intestinal abnormality and necrotising enterocolitis

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Division of NeonatologyRecruiting

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 for 3 days

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

To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2012
Last Updated
December 13, 2012
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01544972
Brief Title
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
Official Title
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

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 oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
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

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, Serum levels, Preterm infant

7. Study Design

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

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 for 3 days
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.
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
To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
Description
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.
Time Frame
up to 6 months

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 Severe thrombocytopenia < 60.000 Severe intracranial bleeding (Grade III - IV) Intestinal abnormality and necrotising enterocolitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadık Yurttutan, MD
Email
sdkyurttutan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Yekta Oncel, MD
Email
dryekta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadık Yurttutan, 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
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ugur Dilmen, Professor
Email
ugurdilmen@gmail.com
First Name & Middle Initial & Last Name & Degree
Omer Erdeve, As.Prof
Email
omererdeve@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sadık Yurttutan, MD

12. IPD Sharing Statement

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

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