Effect of Prematurity on Renal Function in 5 Years Old Children - Full Text View

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

This study is currently recruiting participants.

Verified by Maternite Regionale Universitaire, January 2009

First Received: January 6, 2009 No Changes Posted

Sponsored by:	Maternite Regionale Universitaire
Information provided by:	Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:	NCT00817921

Purpose

Purpose of the study:

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

Condition
Renal Function Blood Pressure

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:

Creatinine clearance [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

growth [ Time Frame: at 3, 4 and 5 years of age ] [ Designated as safety issue: No ]
Blood Pressure [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
Hemodynamic tolerance to mild exercise [ Time Frame: 3, 4 and 5 years of age ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood and urine samples

Estimated Enrollment:	468
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 former premature children treated by ibuprofen
2 former premature children not treated by ibuprofen
3 former term children (control)

Eligibility

Ages Eligible for Study:	3 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817921

Contacts

Contact: Jean-Michel HASCOET, MD	+33 383 343 645	jm.hascoet@maternite.chu-nancy.fr
Contact: Rachel VIEUX, MD	+33 383 344 331	r.vieux@maternite.chu-nancy.fr

Locations

France
Maternite Regionale Universitaire	Recruiting
Nancy, France, 54042
Contact: Jean-Michel HASCOET, MD +33 383 343 645 jm.hascoet@maternite.chu-nancy.fr
Contact: Marie-Christine BUCHWEILLER, RN +33 383 344 331 mc.buchweiller@maternite.chu-nancy.fr
Sub-Investigator: Rachel VIEUX, MD
AP-HM (Néonatologie)	Active, not recruiting
MARSEILLE, France, 13000
CHU	Active, not recruiting
DIJON, France, 21079

Sponsors and Collaborators

Maternite Regionale Universitaire

Investigators

Principal Investigator:

Jean-Michel HASCOET, MD

Maternite Regionale Universitaire

More Information

No publications provided

Responsible Party:	Maternite Regionale Universitaire ( Bruno CARRIERE / Director )
Study ID Numbers:	MRU-07-11
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00817921 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Maternite Regionale Universitaire:

premature renal function
ibuprofen
blood pressure

Study placed in the following topic categories:

Ibuprofen

ClinicalTrials.gov processed this record on September 02, 2009