Sudden Unexpected Infant Death, Air Pollution, PesticidesExpoMINNCT06708793
Environmental Exposures and Sudden Unexpected Infant Death
An observational study of Sudden Unexpected Infant Death, Air Pollution, Pesticides, run by Nantes University Hospital at 1 site in France.
Trial summary
This project is a descriptive study designed to identify the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. French national registry of STUDY of Sudden Unexpected Infant Death. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Sudden Unexpected Infant Death, Air Pollution, Pesticides
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 31 Aug 2026
- 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 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The entire population concerns infants who died of MIN and are included in the OMIN registry. For the ambient air pollution axis, the inclusion criterion is the availability of geolocation (GPS) of the residence. For the pesticides axis, the inclusion criterion is the presence of biological samples in the 3 matrices of interest: serum, hair and cerebrospinal fluid.
Who may be able to join
- Died and include in French registry of sudden infant death syndrome
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Environmental Exposures and Sudden Unexpected Infant Death : a Descriptive Study From the French Prospective Multisite Registry (OMIN)
This project is a descriptive study designed to identify the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. French national registry of STUDY of Sudden Unexpected Infant Death.
Read the detailed description
This project is a descriptive study designed to estimate the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. These two types of pollutants represent two important determinants of environmental health. Although their emission sources and chemical composition differ, these pollutants carry the risk of multiple toxicities that can contribute to the occurrence of Unexpected Infant Death Syndrome (SUID), and are widely present in France, in the air as well as in food, waterways, soils, etc. These two approaches have enabled us to develop two complementary methodologies: geostatistics associated with environmental epidemiology for air pollutants, and analytical environmental chemistry for pesticides.
In addition to matching these exposure measurements with data from the OMIN registry, we will be able to address the impact and determinants of these exposures - i.e., to highlight the individual and collective characteristics that favor high exposure, and to address the toxicological mechanisms linked to these exposures and that may contribute to the occurrence of SUID in general.
- Keywords
- Sudden unexpected infant death, Sudden infant death syndrome, Perinatal death
- Medical subject headings
- Sudden Infant Death, Perinatal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeling cumulative exposure to several contaminants in ambient air, to ambient temperature in France and to pesticides through proximity to crops, and cross-referencing with data from the OMIN registry
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexpected Infant Death, Air Pollution, PesticidesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AXA Assurances VIE Mutuelle, ANSES
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708793
- Sponsor's protocol ID
- RC23_0513
- Acronym
- ExpoMIN
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Exposures and Sudden Unexpected Infant Death : a Descriptive Study From the French Prospective Multisite Registry (OMIN)
- ClinicalTrials.gov ID
- NCT06708793
- Acronym / sponsor ID
- ExpoMIN / RC23_0513
- Keywords
- Sudden unexpected infant death, Sudden infant death syndrome, Perinatal death
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- AXA Assurances VIE Mutuelle, ANSES
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Nov 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.
This project is a descriptive study designed to identify the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. French national registry of STUDY of Sudden Unexpected Infant Death.
Detailed description
This project is a descriptive study designed to estimate the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. These two types of pollutants represent two important determinants of environmental health. Although their emission sources and chemical composition differ, these pollutants carry the risk of multiple toxicities that can contribute to the occurrence of Unexpected Infant Death Syndrome (SUID), and are widely present in France, in the air as well as in food, waterways, soils, etc. These two approaches have enabled us to develop two complementary methodologies: geostatistics associated with environmental epidemiology for air pollutants, and analytical environmental chemistry for pesticides.
In addition to matching these exposure measurements with data from the OMIN registry, we will be able to address the impact and determinants of these exposures - i.e., to highlight the individual and collective characteristics that favor high exposure, and to address the toxicological mechanisms linked to these exposures and that may contribute to the occurrence of SUID in general.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire population concerns infants who died of MIN and are included in the OMIN registry. For the ambient air pollution axis, the inclusion criterion is the availability of geolocation (GPS) of the residence. For the pesticides axis, the inclusion criterion is the presence of biological samples in the 3 matrices of interest: serum, hair and cerebrospinal fluid.
Key inclusion criteria (1 listed)
- Died and include in French registry of sudden infant death syndrome
Key exclusion criteria (1 listed)
- None
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
Modeling cumulative exposure to several contaminants in ambient air, to ambient temperature in France and to pesticides through proximity to crops, and cross-referencing with data from the OMIN registry
Time frame: one year
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 3 Dec 2024.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Unexpected Infant Death, Air Pollution, Pesticides, run by Nantes University Hospital at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modeling cumulative exposure to several contaminants in ambient air, to ambient temperature in France and to pesticides through proximity to crops, and cross-referencing with data from the OMIN registry (time frame: one year). 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 3 Dec 2024.