Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268444
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-13
Brief Title:
Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Infant Sleep and Exposure to Mixture of Environmental Pollutants
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLANGE
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 child39s 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 infant39s milk breastfeeding and wearing a silicone bracelet to collect air pollutants A questionnaire on exposure will complement this evaluation
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 infant39s milk breastfeeding and wearing a silicone bracelet to collect air pollutants A questionnaire on exposure will complement this evaluation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None