PERINE : Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain : an MRI Study

NCT ID: NCT02125110

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-10-31

Brief Summary

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This project aims at evaluating the consequences of prenatal exposure to neurotoxicants (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to 12 years.

Detailed Description

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Conditions

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Effects of Neurotoxicants on the Brain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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study group (cohort PELAGIE)

100 children included in the cohort PELAGIE

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

neuropsychological assessment

Intervention Type OTHER

pilot group (no cohort PELAGIE)

10 children not included in the PELAGIE cohort to optimise MRI

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

Interventions

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MRI

Intervention Type DEVICE

neuropsychological assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children included in the cohort PELAGIE
* Children participated in the study PEPSY
* Age between 10 and 12 years (pilot study)

Exclusion Criteria

* Maternal smoking and or alcohol consumption during pregnancy (study group)
* Children with a health event affecting neurodevelopment
* Children treated with methylphenidate, psychotropic or anti-epileptics
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Rennes

Rennes, , France

Site Status

Countries

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France

References

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Binter AC, Bannier E, Simon G, Saint-Amour D, Ferre JC, Barillot C, Monfort C, Cordier S, Chevrier C, Pele F. Prenatal exposure to glycol ethers and motor inhibition function evaluated by functional MRI at the age of 10 to 12 years in the PELAGIE mother-child cohort. Environ Int. 2019 Dec;133(Pt A):105163. doi: 10.1016/j.envint.2019.105163. Epub 2019 Sep 11.

Reference Type RESULT
PMID: 31518935 (View on PubMed)

Other Identifiers

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2013-A01420-45

Identifier Type: -

Identifier Source: org_study_id

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