A Phase 4 interventional study of Oral paracetamol and Oral ibuprofen in Patent Ductus Arteriosus, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to participants aged 2 Days to 10 Days. Per ClinicalTrials.gov, last updated 2012-12-17.
Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Phase 4, Interventional, and Diagnostic
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
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.
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Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days
Drug: Oral paracetamol
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 paracetamol 15 mg/kg per dose every 6 hours.
Also known as: Calpol
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Also known as: Pedifen
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.
Time frame: up to 6 months
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Zekai Tahir Burak Women's Health Research and Education Hospital