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

NCT02125110 | Completed DMC

• 1 other identifier: 2013-A01420-45
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effects of Neurotoxicants on the Brain

Keywords

neurotoxicants; MRI; developing brain

Outcome Measures

Primary Outcomes (1)

• Measurement of the brain activity and its functionality

  Measurement of the fractional anisotropy of the regions of interest on MRI : \- with DTI (Diffusion Tensor Imaging) : DTI can be used to generate quantitative maps of the scalar (anisotropy, based on measurements of FA and mean diffusivity (MD)) or tensor (diffusivity expressed in the form of a 3x3 matrix) type. An intergroup analysis will be carried out to identify regions with FA and MD values different between exposed and non-exposed subjects. Tractography of the fibre bundles in the white matter could also be carried out, based on regions of interest extracted, for example, from high resolution morphometry or functional activation maps. The connectivity between these different regions may also be studied.

  day 1

Secondary Outcomes (2)

• Measurement of the brain activity and its functionality

  day 1

• Results of neuropsychological tests

  day 1

Study Arms (2)

study group (cohort PELAGIE)

EXPERIMENTAL

100 children included in the cohort PELAGIE

Device: MRI; Other: neuropsychological assessment

pilot group (no cohort PELAGIE)

EXPERIMENTAL

10 children not included in the PELAGIE cohort to optimise MRI

Device: MRI

Interventions

MRI DEVICE

pilot group (no cohort PELAGIE); study group (cohort PELAGIE)

neuropsychological assessment OTHER

study group (cohort PELAGIE)

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

Location

Related Publications (1)

• 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.

  PMID: 31518935 RESULT

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)