Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

NCT ID: NCT06268444

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn Chemical Pollutants Exposure Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

New born

Group Type EXPERIMENTAL

7-day actimetry sleep recording

Intervention Type DEVICE

7-day actimetry sleep recording

Determination of environmental pollutants in breast milk

Intervention Type OTHER

Determination of environmental pollutants in breast milk

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Intervention Type OTHER

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Continuous recording of the child's temperature for 7 days

Intervention Type OTHER

Continuous recording of the child\'s temperature for 7 days

Use of a sleep diary for 7 days

Intervention Type OTHER

Use of a sleep diary for 7 days

Parental questionnaire of environmental exposure

Intervention Type OTHER

Parental questionnaire of environmental exposure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

7-day actimetry sleep recording

7-day actimetry sleep recording

Intervention Type DEVICE

Determination of environmental pollutants in breast milk

Determination of environmental pollutants in breast milk

Intervention Type OTHER

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Intervention Type OTHER

Continuous recording of the child's temperature for 7 days

Continuous recording of the child\'s temperature for 7 days

Intervention Type OTHER

Use of a sleep diary for 7 days

Use of a sleep diary for 7 days

Intervention Type OTHER

Parental questionnaire of environmental exposure

Parental questionnaire of environmental exposure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infant less than 6 months of age still on milk diet (total)

Exclusion Criteria

* Infants with neurological or neurobehavioral disorders
* Families who wish to relocate within 7 days of inclusion
* Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
* Non-affiliation to a social security system
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU Amiens

Amiens, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karen CHARDON, Pr

Role: CONTACT

(33) 03.22.82.78. 65

Elodie HARAUX, Pr

Role: CONTACT

(33) 03.22.08.75.60

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karen CHARDON, Pr

Role: primary

03.22.82.78. 65

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2023_843_0077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Odors to Insufflate Life
NCT02851979 TERMINATED NA