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

NCT06726824 | Not Yet Recruiting

• 1 other identifier: RNI 2024 BERNARD
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neurodevelopmental Disorder (Diagnosis)

Keywords

Neurodevelopmental disorder; Multiexposure; Medical devices; Plasticizers; Cocktail effects

Outcome Measures

Primary Outcomes (2)

• ASQ3® score translated into an overall numerical score corresponding to the total of 5 dimensions of the ASQ3 test.

  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.

  From en recollement to the end of the teleconsultation

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Lille

Lille, France

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)