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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Patent ductus arteriosus
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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

rate of ductal closure

Secondary Outcome

 rate of side effects

Condition

Patent Ductus Arteriosus

Intervention

oral ibuprofen

Study Arms / Comparison Groups

 I
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

62

Start Date

January 2007

Completion Date

December 2007

Primary Completion Date

March 2007

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.

Gender

All

Ages

N/A - 96 Hours

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Tunisia

Location Countries

Tunisia

Administrative Informations

NCT ID

NCT00642330

Organization ID

IBU-001

Secondary IDs

TIS-1447

Study Sponsor

Hopital La Rabta

Collaborators

 maternity and neonatal center

Study Sponsor

, ,

Verification Date

March 2008