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MecoExpo Study Protocol

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Infant, Newborn

Treatments

Other: meconium

Study type

Interventional

Funder types

Other

Identifiers

NCT02899819
PI10-PR-BACH

Details and patient eligibility

About

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:

  1. 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.).
  2. map pesticide exposure across the Picardie region.
  3. create a meconium bank in Picardie (the first ever meconium bank in France).

Enrollment

1,020 patients

Sex

All

Ages

Under 2 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,020 participants in 1 patient group

meconium
Experimental group
Description:
The meconium will be sampled in the first 2 days of life
Treatment:
Other: meconium

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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