Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
NCT ID: NCT01544972
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion Criteria
* Severe thrombocytopenia \< 60.000
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis
2 Days
10 Days
ALL
No
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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Sadik Yurttutan
Zekai Tahir Burak Maternity and Teaching Hospital
Principal Investigators
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Sadık Yurttutan, MD
Role: PRINCIPAL_INVESTIGATOR
Zekai Tahir Burak Women's Health Research and Education Hospital
Locations
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Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Ugur Dilmen, Professor
Role: primary
Omer Erdeve, As.Prof
Role: backup
Other Identifiers
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ZTB170212
Identifier Type: -
Identifier Source: org_study_id