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

Not yet recruiting

• Conditions: Neurodevelopmental Disorder (Diagnosis)

• Registration Number: NCT06726824
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Lille; 🇫🇷 Lille, France