Patent Ductus Arteriosus
Conditions
Keywords
Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Serum levels, Preterm infant
Brief summary
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
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
Interventions
DRUGOral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
DRUGOral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Sponsors
Zekai Tahir Burak Women's Health Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Days to 10 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA | up to 6 months | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSadık Yurttutan, MD
Backup ContactMehmet Yekta Oncel, MD
Outcome results
None listed