NCT00817921

Brief Summary

Purpose of the study:

  1. 1.To evaluate the effect of prematurity on renal function in 5 years old children
  2. 2.To compare former premature children treated by ibuprofen in the neonatal period to controls

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

4.1 years

First QC Date

January 6, 2009

Last Update Submit

February 4, 2014

Conditions

Prematurity of Fetus

Keywords

premature renal functionibuprofenblood pressureRenal function

Outcome Measures

Primary Outcomes (1)

  • Creatinine clearance

    5 years of age

Secondary Outcomes (7)

  • Growth

    at 3 years of age

  • Blood Pressure

    5 years of age

  • Hemodynamic tolerance to mild exercise

    3 years of age

  • Growth

    4 years of age

  • Growth

    5 years of age

  • +2 more secondary outcomes

Study Arms (3)

1

former premature children treated by ibuprofen

2

former premature children not treated by ibuprofen

3

former term children (control)

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)

You may not qualify if:

  • lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU

Dijon, 21079, France

Location

AP-HM (Néonatologie)

Marseille, 13000, France

Location

Maternite Regionale Universitaire

Nancy, 54042, France

Location

Related Publications (1)

  • Vieux R, Hascoet 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.

    PMID: 22261507DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

Study Officials

  • Jean-Michel HASCOET, MD

    Maternite Regionale Universitaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

FR(3)