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

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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