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:
Collaborator:
maternity and neonatal center
Information provided by:
Hopital La Rabta
ClinicalTrials.gov Identifier:
NCT00642330
First received: March 17, 2008
Last updated: March 24, 2008
Last verified: March 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 [ 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
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

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
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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:
Additional 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
Study First Received: March 17, 2008
Last Updated: March 24, 2008
Health Authority: Tunisia: Ministry of Public Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014