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
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
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
Condition
Patent Ductus Arteriosus
Intervention
Oral paracetamol
Study Arms / Comparison Groups
Oral paracetamol
Description: Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
February 2012
Completion Date
December 2012
Primary Completion Date
December 2012
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
Gender
All
Ages
N/A - 10 Days
Accepts Healthy Volunteers
No
Contacts
Sadık Yurttutan, MD, , [email protected]
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT01544972
Organization ID
ZTB170212
Responsible Party
Principal Investigator
Study Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor
Sadık Yurttutan, MD, Principal Investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date
December 2012