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

Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen

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.

Study Overview

• Status: Unknown
• Conditions: Patent Ductus Arteriosus
• Intervention / Treatment: Drug: Oral paracetamol; Drug: Oral ibuprofen

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
    • Contact: Ugur Dilmen, Professor; Email: ugurdilmen@gmail.com
    • Contact: Omer Erdeve, As.Prof; Email: omererdeve@yahoo.com
    • Principal Investigator: Sadık Yurttutan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Pedifen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (ESTIMATE): March 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Ibuprofen; Paracetamol; Preterm infant; Patent Ductus Arteriosus; Serum levels
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: ZTB170212