NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders (NEOMIX WP3)

December 6, 2024 updated by: University Hospital, Clermont-Ferrand

The goal of this observational study is to evaluate the neurodevelopment of children from the ARMED NEO cohort through the ASQ3 score.

Dose the multiexposure to medical devices plasticizers during the neonatal intensive care unit stay increases the risk of developing neurodevelopmental disorders ? Patients (their parents) will complète several questionnaires (ASQ3, environnemental survey, EPICES score) during a planned teleconsultation with the research team

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France
      • Lille, France
        • CHU de Lille
        • Principal Investigator:
          • Laurent STORME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruted in Clermont-Ferrand And Lille centers. They are ambulatory patients whose parents Will be contacted by phone by research team to plan, if they accept to participate, a teleconsultation

Description

Inclusion Criteria:

  • Live patient who participated in the ARMED NEO study, included at the Clermont-Ferrand or Lille hospitals
  • Patient whose holders of parental authority have expressed their non-opposition to their participation in the study

Exclusion Criteria:

  • Patient whose guardians have expressed opposition to their participation in the study
  • Patient with no French speaking parent
  • patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NEOMIX-WP3 cohort
NEOMIX-WP3 cohort corresponds to the patients incluses in the ARMED NEO cohort (NICU patients) between February 2018 And June 2019. These children are now between 6 And 7. Their parents will be asked by validated questionnaries to evaluate the Neurodevelopmental status And eventual risk factors since they got back home after NICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASQ3® score translated into an overall numerical score corresponding to the total of 5 dimensions of the ASQ3 test.
Time Frame: From enrollment to the end of the teleconsultation
From enrollment to the end of the teleconsultation
ASQ3® score translated into an overall numerical score corresponding to the total of 5 dimensions of the ASQ3 test.
Time Frame: From en recollement to the end of the teleconsultation
From en recollement to the end of the teleconsultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2024 BERNARD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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