Ibuprofen and Renal Function in Premature Infants

September 18, 2006 updated by: Maternite Regionale Universitaire

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

120

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

  • France
      • Dijon, France, 21079
        • CHU
      • Marseille, France, 13000
        • AP-HM (Néonatologie)
      • Nancy, France, 54042
        • Maternite Regionale Universitaire

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

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Creatinine Clearance on day seven postnatally

Secondary Outcome Measures

Outcome Measure
Mortality
Rate of ductus closure after treatment
Rate of necrotizing enterocolitis
Rate and severity of Intraventricular Hemorrhage
Renal function maturation over 28 days

Collaborators and Investigators

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

Sponsor

Maternite Regionale Universitaire

Collaborators

Central Hospital, Nancy, France
Ministere de la Sante et de la Protection Sociale, France

Investigators

  • Study Director: Jean-Michel HASCOET, MD, University of NANCY, France

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

September 1, 2004

Primary Completion

December 7, 2022

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2006

Last Update Submitted That Met QC Criteria

September 18, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRAP040833
  • PHRC2004:17-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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