Effect of Prematurity on Renal Function in 5 Years Old Children (SUIVIREIN)

February 4, 2014 updated by: Jean Michel Hascoet

Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls

Purpose of the study:

  1. To evaluate the effect of prematurity on renal function in 5 years old children
  2. To compare former premature children treated by ibuprofen in the neonatal period to controls

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

168

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

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children from a previous trial followed at 3, 4 and 5 years of age

Description

Inclusion Criteria:

  • Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)

Exclusion Criteria:

  • lack of parental consent

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

Cohorts and Interventions

Group / Cohort
1
former premature children treated by ibuprofen
2
former premature children not treated by ibuprofen
3
former term children (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creatinine clearance
Time Frame: 5 years of age
5 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth
Time Frame: at 3 years of age
at 3 years of age
Blood Pressure
Time Frame: 5 years of age
5 years of age
Hemodynamic tolerance to mild exercise
Time Frame: 3 years of age
3 years of age
Growth
Time Frame: 4 years of age
4 years of age
Growth
Time Frame: 5 years of age
5 years of age
Hemodynamic tolerance to mild exercise
Time Frame: 4 years of age
4 years of age
Hemodynamic tolerance to mild exercise
Time Frame: 5 years of age
5 years of age

Collaborators and Investigators

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

Sponsor

Jean Michel Hascoet

Investigators

  • Principal Investigator: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire

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

November 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRU-07-11

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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