Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants - Full Text View

Sponsors and Collaborators:	Hopital La Rabta maternity and neonatal center
Information provided by:	Hopital La Rabta
ClinicalTrials.gov Identifier:	NCT00642330

Purpose

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.

Condition	Intervention	Phase
Patent Ductus Arteriosus	Drug: oral ibuprofen Drug: intravenous ibuprofen	Phase IV

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus

Further study details as provided by Hopital La Rabta:

Primary Outcome Measures:

rate of ductal closure [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of side effects [ Designated as safety issue: Yes ]

Enrollment:	62
Study Start Date:	January 2007
Study Completion Date:	December 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator	Drug: intravenous ibuprofen 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.
O: Active Comparator	Drug: oral ibuprofen 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.

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.

Eligibility

Ages Eligible for Study:	up to 96 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642330

Locations

Tunisia
Maternity and Neonatal Center
tunis, Tunisia, 1007

Sponsors and Collaborators

Hopital La Rabta

maternity and neonatal center

More Information

Publications:

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. Epub 2007 Jun 12.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Hopital La Rabta ( khrouf naima )
Study ID Numbers:	IBU-001, TIS-1447, FMND-4585
Study First Received:	March 17, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642330 History of Changes
Health Authority:	Tunisia: Ministry of Public Health

Keywords provided by Hopital La Rabta:

patent
ductus
arteriosus

ibuprofen
premature
infant

Study placed in the following topic categories:

Birth Weight
Anti-Inflammatory Agents
Ibuprofen
Heart Diseases
Cardiovascular Abnormalities
Patent Ductus Arteriosus
Cyclooxygenase Inhibitors
Body Weight
Signs and Symptoms

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Birth Weight
Ibuprofen
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiovascular Abnormalities
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Body Weight
Signs and Symptoms

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Congenital Abnormalities
Central Nervous System Agents
Heart Defects, Congenital
Ductus Arteriosus, Patent

ClinicalTrials.gov processed this record on May 07, 2009