Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
oral ibuprofen
intravenous ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring patent, ductus, arteriosus, ibuprofen, premature, infant
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.
Sites / Locations
- Maternity and Neonatal Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I
O
Arm Description
Outcomes
Primary Outcome Measures
rate of ductal closure
Secondary Outcome Measures
rate of side effects
Full Information
NCT ID
NCT00642330
First Posted
March 17, 2008
Last Updated
March 24, 2008
Sponsor
Hopital La Rabta
Collaborators
maternity and neonatal center
1. Study Identification
Unique Protocol Identification Number
NCT00642330
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hopital La Rabta
Collaborators
maternity and neonatal center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
patent, ductus, arteriosus, ibuprofen, premature, infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Title
O
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
oral ibuprofen
Intervention Description
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 oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
Intervention Type
Drug
Intervention Name(s)
intravenous ibuprofen
Intervention Description
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 oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
Primary Outcome Measure Information:
Title
rate of ductal closure
Secondary Outcome Measure Information:
Title
rate of side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Hours
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Maternity and Neonatal Center
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17564958
Citation
Cherif A, Jabnoun S, Khrouf N. Oral ibuprofen in early curative closure of patent ductus arteriosus in very premature infants. Am J Perinatol. 2007 Jun;24(6):339-45. doi: 10.1055/s-2007-981853. Epub 2007 Jun 12.
Results Reference
result
PubMed Identifier
19047225
Citation
Cherif A, Khrouf N, Jabnoun S, Mokrani C, Amara MB, Guellouze N, Kacem S. Randomized pilot study comparing oral ibuprofen with intravenous ibuprofen in very low birth weight infants with patent ductus arteriosus. Pediatrics. 2008 Dec;122(6):e1256-61. doi: 10.1542/peds.2008-1780.
Results Reference
derived
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Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
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