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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT00817921
First received: January 6, 2009
Last updated: February 4, 2014
Last verified: February 2014

January 6, 2009
February 4, 2014
November 2008
December 2012   (final data collection date for primary outcome measure)
Creatinine clearance [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00817921 on ClinicalTrials.gov Archive Site
  • Growth [ Time Frame: at 3 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 years of age ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 4 years of age ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • Hemodynamic tolerance to mild exercise [ Time Frame: 4 years of age ] [ Designated as safety issue: Yes ]
  • Hemodynamic tolerance to mild exercise [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effect of Prematurity on Renal Function in 5 Years Old Children
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood and urine samples

Non-Probability Sample

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

Prematurity of Fetus
Not Provided
  • 1
    former premature children treated by ibuprofen
  • 2
    former premature children not treated by ibuprofen
  • 3
    former term children (control)
Vieux R, Hascoët JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
3 Years to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00817921
MRU-07-11
No
Jean Michel Hascoet, Maternite Regionale Universitaire
Jean Michel Hascoet
Not Provided
Principal Investigator: Jean-Michel HASCOET, MD Maternite Regionale Universitaire
Maternite Regionale Universitaire
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP