Effect of Prematurity on Renal Function in 5 Years Old Children

Completed

• Conditions: Prematurity of Fetus

• Registration Number: NCT00817921
• Lead Sponsor: Jean Michel Hascoet

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creatinine clearance	5 years of age

Secondary Outcome Measures

Name	Time	Method
Growth	5 years of age
Hemodynamic tolerance to mild exercise	5 years of age
Blood Pressure	5 years of age

Trial Locations

Locations (3)

CHU; 🇫🇷 Dijon, France

AP-HM (Néonatologie); 🇫🇷 Marseille, France

Maternite Regionale Universitaire; 🇫🇷 Nancy, France