Status:

WITHDRAWN

TEXTO : Total EXposure To Organic Pollutants

Lead Sponsor:

Rennes University Hospital

Collaborating Sponsors:

Institut de Recherche en Santé, Environnement et le Travail, France

Laboratoire d'Etude des Résidus et Contaminants dans les Aliments

Conditions:

Healthy

Eligibility:

All Genders

6-18 years

Phase:

NA

Brief Summary

People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal con...

Detailed Description

Pilot study for testing feasibility of cross sectional integrative exposure study. Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and exter...

Eligibility Criteria

Inclusion

  • Young children (2-6 months ; 12-18 months)
  • In outpatient pediatric or pediatric surgery ;
  • From their homes ;
  • With home located less than 30km from Rennes ;
  • Living at their home (not at childcare facility or child-minder);
  • With a scheduled blood sampling apart from this study ;
  • For child 2 - 6 months :
  • With diet exclusively based on milk (maternal exclusively or commercial exclusively)
  • In case of breastfeeding, with mother accepting milk sampling ;
  • With a free, enlightened and signed written consent from the parents.
  • Breastfeeding mother :
  • \> 18 years ;
  • Exclusive breastfeeding ;
  • With a free, enlightened and signed written consent.

Exclusion

  • Children :
  • Metabolic illness ;
  • Renal or hepatic insufficiency ;
  • Malabsorption
  • With known HIV+, HBV+, HCV+, CMV+ serology
  • Simultaneously participating to other biomedical survey
  • For breastfeeding mother :
  • Under legal protection (judicial protection, guardianship) ;
  • mixed breastfeeding ;
  • with Known HIV+, HBV+, HCV+, CMV+ serology

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02210299

Start Date

September 1 2014

End Date

May 1 2015

Last Update

June 10 2015

Active Locations (1)

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Rennes Hospital University

Rennes, Brittany Region, France, 35033