Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

Sleep Clinical Trial

— SOLANGE  

Official title:

Infant Sleep and Exposure to Mixture of Environmental Pollutants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268444
• Other study ID #: PI2023_843_0077
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Karen CHARDON, Pr
• Phone: (33) 03.22.82.78. 65
• Email: Karen.chardon[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Newborn
• Sleep

Intervention

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
• 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
• Continuous recording of the child's temperature for 7 days
Continuous recording of the child's temperature for 7 days
• Use of a sleep diary for 7 days
Use of a sleep diary for 7 days
• Parental questionnaire of environmental exposure
Parental questionnaire of environmental exposure

Locations

Country	Name	City	State
France	CHRU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total sleep time per day in infants using actimetry	total sleep time per day (min)) in infants using actimetry	7 days
Secondary	Concentration of various substances in breast milk		1 day
Secondary	concentration of chemical polluants on newborn bracelets		1 day
Secondary	Child Temperature level (°C)		7 days