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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT00817921
First received: January 6, 2009
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Condition
Prematurity of Fetus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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:

MedlinePlus related topics: Premature Babies
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 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 ]

Biospecimen Retention:   Samples Without DNA

Blood and urine samples


Estimated Enrollment: 468
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (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

Locations
France
CHU
Dijon, France, 21079
AP-HM (Néonatologie)
Marseille, France, 13000
Maternite Regionale Universitaire
Nancy, France, 54042
Sponsors and Collaborators
Jean Michel Hascoet
Investigators
Principal Investigator: Jean-Michel HASCOET, MD Maternite Regionale Universitaire
  More Information

No publications provided by Maternite Regionale Universitaire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jean Michel Hascoet, Professor, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00817921     History of Changes
Other Study ID Numbers: MRU-07-11
Study First Received: January 6, 2009
Last Updated: March 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:
premature renal function
ibuprofen
blood pressure
Renal function

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013