Brief Title
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
Official Title
Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus
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 very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.
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 intravenous ibuprofen groups, assuming a closure rate of 65 percent with intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.Patients (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group I, n = 32) or oral ibuprofen (group O, n = 32), starting on the third day of life. The rate of ductal closure, side effects, complications, and the patients' clinical course will be recorded.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
rate of ductal closure
Secondary Outcome
rate of side effects
Condition
Patent Ductus Arteriosus
Intervention
oral ibuprofen
Study Arms / Comparison Groups
I
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
62
Start Date
January 2007
Completion Date
December 2007
Primary Completion Date
March 2007
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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.
Gender
All
Ages
N/A - 96 Hours
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Tunisia
Location Countries
Tunisia
Administrative Informations
NCT ID
NCT00642330
Organization ID
IBU-001
Secondary IDs
TIS-1447
Study Sponsor
Hopital La Rabta
Collaborators
maternity and neonatal center
Study Sponsor
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Verification Date
March 2008