Effect of Prematurity on Renal Function in 5 Years Old Ch... | NCT00817921

Studies
Effect of Prematurity on Renal Function in 5 Years Old Children

NCT00817921

Sponsor

Jean Michel Hascoet

Status

Completed

Last Update Posted

Feb 5, 2014Estimated

Enrollment

168Actual

Phase

Not provided

Conditions

Prematurity of Fetus

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 6, 2009

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose of the study:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		former premature children treated by ibuprofen
2		former premature children not treated by ibuprofen
3		former term children (control)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creatinine clearance		5 years of age

Secondary Outcomes

Measure	Description	Time Frame
Growth		at 3 years of age
Blood Pressure		5 years of age
Hemodynamic tolerance to mild exercise

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Michel HASCOET, MD	Maternite Regionale Universitaire	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU		Dijon		21079	France
AP-HM (Néonatologie)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22261507	Derived	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.