Patent Ductus Arteriosus Clinical Trial
Official title:
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.
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
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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