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Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

Infant Sleep and Exposure to Mixture of Environmental Pollutants

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06268444
Acronym
SOLANGE
Enrollment
120
Registered
2024-02-20
Start date
2024-02-07
Completion date
2026-02-28
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemical Pollutants Exposure, Newborn, Sleep

Keywords

sleep, Newborn, chemical pollutants exposure

Brief 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.

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
total sleep time per day in infants using actimetry7 daystotal sleep time per day (min)) in infants using actimetry

Secondary

MeasureTime frame
Concentration of various substances in breast milk1 day
concentration of chemical polluants on newborn bracelets1 day
Child Temperature level (°C)7 days

Countries

France

Contacts

Primary ContactKaren CHARDON, Pr
Karen.chardon@u-picardie.fr(33) 03.22.82.78. 65
Backup ContactElodie HARAUX, Pr
Haraux.elodie@chu-amiens.fr(33) 03.22.08.75.60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026