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
  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:


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


Enrollment: 168
Study Start Date: November 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 4, 2014
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 September 18, 2014