MecoExpo Study Protocol

Study Overview
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Brief Summary
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The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie. These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery). Thus, the MecoExpo project will enable the investigators to: evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.). map pesticide exposure across the Picardie region. create a meconium bank in Picardie (the first ever meconium bank in France).

Official Title
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MecoExpo Study Protocol

Conditions
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Infant, Newborn

Intervention / Treatment
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* Other: meconium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newborns in Picardie will be eligible. Good command of the French language by a least one of the two people with responsibility for the child will be required for filling out the questionnaire. The mother's place of residence must have been in Picardie during the last two trimesters of pregnancy. Exclusion Criteria: Newborns with foetal distress

Ages Eligible for Study
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Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meconium<br>The meconium will be sampled in the first 2 days of life | Other: meconium<br>* The meconium will be sampled in the first 2 days of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fœtal vs mother exposure - term | evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and term at birth | Day 2 | 
| fœtal vs mother exposure - length | evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and length at birth | Day 2 | 
| fœtal vs mother exposure - weight | evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and weight at birth | Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pesticides, exposure, in utero