NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorder (Diagnosis). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- CHU Clermont-Ferrand — Clermont-Ferrand
- CHU de Lille — Lille
Identifiers
NCT: NCT06726824 · RNI 2024 BERNARD