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

Study Overview
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Brief Summary
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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
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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

Official Title
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Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: Oral paracetamol
* Drug: Oral ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral paracetamol<br>Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days | Drug: Oral paracetamol<br>* Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.<br>* Other names: Calpol;|
| Active Comparator: Oral ibuprofen<br>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<br>* Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.<br>* Other names: Pedifen;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Serum levels, Preterm infant