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

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ClinicalTrials.gov Identifier: NCT00817921
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Prematurity of Fetus

Study Design

Study Type : Observational
Actual Enrollment : 168 participants
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
Study Start Date : November 2008
Primary Completion Date : December 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
Drug Information available for: Ibuprofen
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
former premature children treated by ibuprofen
2
former premature children not treated by ibuprofen
3
former term children (control)


Outcome Measures

Primary Outcome Measures :
  1. Creatinine clearance [ Time Frame: 5 years of age ]

Secondary Outcome Measures :
  1. Growth [ Time Frame: at 3 years of age ]
  2. Blood Pressure [ Time Frame: 5 years of age ]
  3. Hemodynamic tolerance to mild exercise [ Time Frame: 3 years of age ]
  4. Growth [ Time Frame: 4 years of age ]
  5. Growth [ Time Frame: 5 years of age ]
  6. Hemodynamic tolerance to mild exercise [ Time Frame: 4 years of age ]
  7. Hemodynamic tolerance to mild exercise [ Time Frame: 5 years of age ]

Biospecimen Retention:   Samples Without DNA
Blood and urine samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Jean Michel Hascoet, Maternite Regionale Universitaire:
premature renal function
ibuprofen
blood pressure
Renal function

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action