Neurodevelopmental Disorder (Diagnosis)NEOMIX WP3NCT06726824
NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders
An observational study of Neurodevelopmental Disorder (Diagnosis), run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorder (Diagnosis)
- How many people
- 97 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient whose guardians have expressed opposition to their participation in the study
- Patient with no French speaking parent
- patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 04.73.75.49.63, promo_interne_drci@chu-clermontferrand.fr
Catherine SARRET
CHU de Lille
Lille
Laurent STORME
About this study
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
- Medical subject headings
- Neurodevelopmental Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
ASQ3® score translated into an overall numerical score corresponding to the total of 5 dimensions of the ASQ3 test.
Measured: 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.
Measured: From en recollement to the end of the teleconsultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Disorder (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726824
- Sponsor's protocol ID
- RNI 2024 BERNARD
- Acronym
- NEOMIX WP3
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT06726824
- Acronym / sponsor ID
- NEOMIX WP3 / RNI 2024 BERNARD
- Conditions
- Neurodevelopmental Disorder (Diagnosis)
- Keywords
- Neurodevelopmental disorder, Multiexposure, Medical devices, Plasticizers, Cocktail effects
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient whose guardians have expressed opposition to their participation in the study
- Patient with no French speaking parent
- patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorder (Diagnosis), run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.