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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 4

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Oral ibuprofen; Drug: Oral paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01544972

ZTB170212

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Oral paracetamol

Active Comparator group

Description:

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days

Treatment:

Drug: Oral paracetamol

Oral ibuprofen

Active Comparator group

Description:

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Treatment:

Drug: Oral ibuprofen