TEXTO : Total EXposure To Organic Pollutants

Rennes University Hospital

Status: Withdrawn

Conditions: Healthy

Treatments: Other: Exposure study

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02210299

14/25-941 (Other Identifier)

140682B-82 (Other Identifier)

2014-A00782-45 (Other Identifier)

35RC13_8917_TEXTO

Details and patient eligibility

About

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 contact...), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.

In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.

The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.

Full 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 external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).

Expected outcomes :

Assessment of feasibility to obtain:

• original data on children's body burden
• original contamination data for food, water, air and dust ;
• Matching of these data to identify main sources and pathways of exposure.

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Exposure study

Other group

Description:

2-6 months-old children and 12-18 months-old children

Treatment:

Other: Exposure study