NCT06708793

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2023Aug 2026

Study Start

First participant enrolled

September 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 26, 2024

Last Update Submit

November 28, 2024

Conditions

Sudden Unexpected Infant Death, Air Pollution, Pesticides

Keywords

Sudden unexpected infant deathSudden infant death syndromePerinatal death

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Died and include in French registry of sudden infant death syndrome

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Sudden Infant DeathPerinatal Death

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 27, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

FR(1)