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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642330
First Posted: March 25, 2008
Last Update Posted: March 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
maternity and neonatal center
Information provided by:
Hopital La Rabta
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus

Resource links provided by NLM:


Further study details as provided by Hopital La Rabta:

Primary Outcome Measures:
  • rate of ductal closure

Secondary Outcome Measures:
  • rate of side effects

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
Active Comparator: I 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.
Active Comparator: O 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

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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642330


Locations
Tunisia
Maternity and Neonatal Center
Tunis, Tunisia, 1007
Sponsors and Collaborators
Hopital La Rabta
maternity and neonatal center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: khrouf naima, Hopital La Rabta
ClinicalTrials.gov Identifier: NCT00642330     History of Changes
Other Study ID Numbers: IBU-001
TIS-1447
FMND-4585
First Submitted: March 17, 2008
First Posted: March 25, 2008
Last Update Posted: March 25, 2008
Last Verified: March 2008

Keywords provided by Hopital La Rabta:
patent
ductus
arteriosus
ibuprofen
premature
infant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Birth Weight
Body Weight
Signs and Symptoms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action