NCT02674087

Brief Summary

The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne. The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these children's lives from the perspectives of health, social sciences and environmental health These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history). This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

April 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 4, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

April 14, 2014

Last Update Submit

February 3, 2016

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

  • Rate of enrollment

    3 years after the study has started, the investigators will evaluate the rate of enrollment.

    At 3 years

Study Arms (1)

Expectant women

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Expectant mother

You may qualify if:

  • Any child born in one of the three maternity hospitals in the Haute-Vienne (CHU Limoges, Clinique des Emailleurs, Hospital Saint-Junien).

You may not qualify if:

  • Children born at home.
  • Children abandoned at birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinique des Emailleurs

Limoges, 87000, France

RECRUITING

HME

Limoges, 87000, France

RECRUITING

Centre Hositalier de Saint Junien

Saint-Junien, 87000, France

RECRUITING

Central Study Contacts

Yves AUBARD, MD

CONTACT

05 55 05 61 07yves.aubard@chu-limoges.fr

Sebastien Mounier

CONTACT

sebastien.mounier@chu-limoges.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2014

First Posted

February 4, 2016

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2019

Last Updated

February 4, 2016

Record last verified: 2016-01

Locations

FR(3)