NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders

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

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Key information

Conditions

Neurodevelopmental Disorder (Diagnosis) Disease Mental Disorders Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: NEOMIX WP3

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 10, 2024
Registry last updated: Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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