Oral Paracetamol Versus Oral Ibuprofen Treatment
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
Study Overview
Brief Summary
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Detailed Description
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 2 Days to 10 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Birth weight below 1250 gram
- •Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion Criteria
- •Accompanied other congenital cardiac anomalies
- •Urine output of less than 1 ml/kg/h during the preceding 8 h,
- •Serum creatinine level >1.6 mg/dl,
- •Platelet count <60,000/mm3,
- •Liver failure,
- •Hyperbilirubinemia requiring exchange transfusion
- •Severe intracranial bleeding (Grade III - IV)
- •Intestinal abnormality and necrotising enterocolitis
Arms & Interventions
Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
Intervention: Oral paracetamol (Drug)
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.
Intervention: Oral ibuprofen (Drug)
Outcomes
Primary Outcomes
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
Time Frame: Until discharge
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
Secondary Outcomes
- Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants(corrected 36 weeks or until discharge)
Investigators
Mehmet Yekta
Zekai Tahir Burak Maternity and Teaching Hospital
Zekai Tahir Burak Women's Health Research and Education Hospital