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

Patent Ductus Arteriosus Clinical Trial

Official title:

Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01544972
• Other study ID #: ZTB170212
• Status: Recruiting
• Phase: Phase 4
• First received: February 22, 2012
• Last updated: December 13, 2012
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Sadik Yurttutan, MD
• Email: sdkyurttutan[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
• 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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 months	Yes