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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Chemical Pollutants Exposure; Newborn; Sleep

Treatments: Other: Determination of environmental pollutants in breast milk; Other: Use of a sleep diary for 7 days; Other: Continuous recording of the child's temperature for 7 days; Other: Parental questionnaire of environmental exposure; Other: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child; Device: 7-day actimetry sleep recording

Study type: Interventional

Funder types: Other

Identifiers

NCT06268444

PI2023_843_0077

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

New born

Experimental group

Treatment:

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

Device: 7-day actimetry sleep recording

Other: Parental questionnaire of environmental exposure

Other: Use of a sleep diary for 7 days

Other: Continuous recording of the child's temperature for 7 days

Other: Determination of environmental pollutants in breast milk