Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants (SOLANGE)

February 13, 2024 updated by: Centre Hospitalier Universitaire, Amiens

Infant Sleep and Exposure to Mixture of Environmental Pollutants

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHRU Amiens
        • Sub-Investigator:
          • Pierre TOURNEUX, Pr
        • Contact:
        • Principal Investigator:
          • Elodie HARAUX, HARAUX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New born
Device: 7-day actimetry sleep recording
7-day actimetry sleep recording
Other: Determination of environmental pollutants in breast milk
Determination of environmental pollutants in breast milk
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
Other: Continuous recording of the child's temperature for 7 days
Continuous recording of the child's temperature for 7 days
Other: Use of a sleep diary for 7 days
Use of a sleep diary for 7 days
Other: Parental questionnaire of environmental exposure
Parental questionnaire of environmental exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total sleep time per day in infants using actimetry
Time Frame: 7 days
total sleep time per day (min)) in infants using actimetry
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of various substances in breast milk
Time Frame: 1 day
1 day
concentration of chemical polluants on newborn bracelets
Time Frame: 1 day
1 day
Child Temperature level (°C)
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2023_843_0077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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