Effect of Prematurity on Renal Function in 5 Years Old Children

Prematurity of Fetus Clinical Trial

— SUIVIREIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817921
• Other study ID #: MRU-07-11
• Status: Completed
• Phase: N/A
• First received: January 6, 2009
• Last updated: February 4, 2014
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Maternite Regionale Universitaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Prematurity of Fetus

Locations

Country	Name	City	State
France	CHU	Dijon
France	AP-HM (Néonatologie)	Marseille
France	Maternite Regionale Universitaire	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Jean Michel Hascoet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine clearance		5 years of age	No
Secondary	Growth		at 3 years of age	No
Secondary	Blood Pressure		5 years of age	No
Secondary	Hemodynamic tolerance to mild exercise		3 years of age	No
Secondary	Growth		4 years of age	No
Secondary	Growth		5 years of age	No
Secondary	Hemodynamic tolerance to mild exercise		4 years of age	Yes
Secondary	Hemodynamic tolerance to mild exercise		5 years of age	No