Ibuprofen and Renal Function in Premature Infants

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Patent ductus arteriosus
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Brief Title

Ibuprofen and Renal Function in Premature Infants

Official Title

Ibuprofen and Renal Function in Premature Infants

Brief Summary

      Purpose of the study:

        1. To evaluate renal function maturation within the first month of life in very premature
           infants.

        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter
           renal function maturation at short term and up to 28 days of life.

Detailed Description

      Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several
      studies showed that Ibuprofen has significantly less side effects than Indomethacin that was
      used for this indication. However, experimental studies and few clinical observations
      suggested that side effects on renal function could occur in very premature infants.

      Purpose of the study:

        1. To evaluate renal function maturation within the first month of life in very premature
           infants.

        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter
           renal function maturation at short term and up to 28 days of life.

      Population:

      At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to
      demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording
      of mother and child history, and associated therapies prone to alter renal function should
      allow to improve the use of this treatment.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Creatinine Clearance on day seven postnatally

Secondary Outcome

 Rate of ductus closure after treatment

Condition

Premature Infants

Intervention

Ibuprofen

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

120

Start Date

September 2004

Completion Date

September 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Gestational Age = 27 to 31 weeks

          -  Postnatal age < 48 hours

          -  Parental Consent Obtained

        Exclusion Criteria:

          -  Renal malformation

          -  Urinary tract infection

          -  Renal Failure

          -  Pulmonary Hypertension at echocardiography

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

Jean-Michel HASCOET, MD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00217191

Organization ID

MRAP040833

Secondary IDs

PHRC2004:17-06

Study Sponsor

Maternite Regionale Universitaire

Collaborators

 Central Hospital, Nancy, France

Study Sponsor

Jean-Michel HASCOET, MD, Study Director, University of Nancy, France

Verification Date

September 2006