Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Ain Shams University
- Enrollment
- 30
- Primary Endpoint
- closure of PDA
Study Overview
Brief Summary
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
Detailed Description
A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.
Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 28 Weeks to 35 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age ≤ 35 weeks
- •Aged 2-7 days with color Doppler echocardiographic evidence of PDA
- •Urine output more than 1 ml/kg/hr
- •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:
- •Congenital heart diseases of any type including
- •Pulmonary stenosis
- •Anomalus in pulmonary venous drainage
- •Ventricular septal defect
- •Major congenital anomalies as hydrops fetalis
- •Low platelets count (less than 60, 000/mm3)
Arms & Interventions
ibuprofen group
treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done
Intervention: ibuprofen (Drug)
paracetamol group
treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done
Intervention: paracetamol (Drug)
Outcomes
Primary Outcomes
closure of PDA
Time Frame: 6 days
Echo confirmed closure
Secondary Outcomes
No secondary outcomes reported
Investigators
Rania Ali El-Farrash
pricipal investigator
Ain Shams University