Overview

Paracetamol Versus Ibuprofen for PDA Closure

Status:
Unknown status
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
Summary
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Acetaminophen
Ibuprofen
Criteria
Inclusion Criteria:

1. Gestational age ≤ 35 weeks

2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA

3. Urine output more than 1 ml/kg/hr

4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

- Pulmonary stenosis

- Anomalus in pulmonary venous drainage

- Ventricular septal defect

2. Major congenital anomalies as hydrops fetalis

3. Low platelets count (less than 60, 000/mm3)