Status:
COMPLETED
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
Lead Sponsor:
Hopital La Rabta
Collaborating Sponsors:
maternity and neonatal center
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
48-96 years
Phase:
PHASE4
Brief Summary
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in ...
Detailed Description
We calculated that a study group of 62 patients would be necessary for the study to be able to detect a difference of at least 25 percentage points in the closure rate between the oral ibuprofen and i...
Eligibility Criteria
Inclusion
- a gestational age \< 32 weeks
- a birth weight \< 1500g
- a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation
- an echocardiographic evidence of left to right significant shunting PDA
Exclusion
- a right-to-left shunting
- major congenital anomalies
- IVH grade 3-4
- a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and / or oozing from puncture sites)
- a serum creatinine level \>140µmol/l, a serum urea nitrogen \> 14 µmol/l and a platelet count \< 60000/mm3.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00642330
Start Date
January 1 2007
End Date
December 1 2007
Last Update
March 25 2008
Active Locations (1)
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1
Maternity and Neonatal Center
Tunis, Tunisia, 1007