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

March 24, 2008 updated by: Hopital La Rabta

Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Maternity and Neonatal Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 4 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rate of ductal closure

Secondary Outcome Measures

Outcome Measure
rate of side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Rabta

Collaborators

maternity and neonatal center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (ESTIMATE)

March 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2008

Last Update Submitted That Met QC Criteria

March 24, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBU-001
  • TIS-1447
  • FMND-4585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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