MecoExpo Study Protocol

Infant, Newborn Clinical Trial

— MecoExpo  

Official title:

MecoExpo Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899819
• Other study ID #: PI10-PR-BACH
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn

Intervention

Other:
• meconium
The meconium will be sampled in the first 2 days of life

Locations

Country	Name	City	State
France	CH Abbeville	Abbeville
France	CHU Amiens	Amiens
France	Groupe Santé Victor Pauchet	Amiens
France	CH Beauvais	Beauvais
France	CH Chateau-Thierry	Chateau-thierry
France	CH Chauny	Chauny
France	CH Compiegne	Compiegne
France	Clinique Saint Come	Compiegne
France	Groupe Hospitalier Public Sud Oise	Creil
France	CH Laon	Laon
France	CH Peronne	Peronne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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