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RecruitingNCT06268444SOLANGEUpdated May 22, 2025

Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

An interventional study of 7-day actimetry sleep recording and Determination of environmental pollutants in breast milk in Newborn, Chemical Pollutants Exposure and Sleep, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
Up to 6 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Newborn
  • Chemical Pollutants Exposure
  • Sleep

Keywords

  • sleep
  • Newborn
  • chemical pollutants exposure
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    New born

    Device: 7-day actimetry sleep recording · Other: Determination of environmental pollutants in breast milk · Other: 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 · Other: Use of a sleep diary for 7 days · Other: Parental questionnaire of environmental exposure

Interventions

  • Device7-day actimetry sleep recording

    7-day actimetry sleep recording

  • OtherDetermination of environmental pollutants in breast milk

    Determination of environmental pollutants in breast milk

  • OtherMeasurements 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

  • OtherContinuous recording of the child's temperature for 7 days

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

  • OtherUse of a sleep diary for 7 days

    Use of a sleep diary for 7 days

  • OtherParental questionnaire of environmental exposure

    Parental questionnaire of environmental exposure

06

What researchers measure

Primary outcomes

  1. total sleep time per day in infants using actimetry

    total sleep time per day (min)) in infants using actimetry

    Time frame: 7 days

Secondary outcomes

  1. Concentration of various substances in breast milk

    Time frame: 1 day

  2. concentration of chemical polluants on newborn bracelets

    Time frame: 1 day

  3. Child Temperature level (°C)

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • CHRU Amiens
    Amiens, 80054, France
    • Karen CHARDON, Pr · Contact · Karen.chardon@u-picardie.fr · 03.22.82.78. 65
    • Elodie HARAUX, HARAUX · Principal investigator
    • Pierre TOURNEUX, Pr · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06268444
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Feb 7, 2024
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
May 22, 2025

Study contacts

Karen CHARDON, Pr
Contact
Karen.chardon@u-picardie.fr
(33) 03.22.82.78. 65
Elodie HARAUX, Pr
Contact
Haraux.elodie@chu-amiens.fr
(33) 03.22.08.75.60

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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