Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

Официальное название

Infant Sleep and Exposure to Mixture of Environmental Pollutants

Обзор

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.

Вмешательства

• Устройство 7-day actimetry sleep recording
  7-day actimetry sleep recording
• Другое Determination of environmental pollutants in breast milk
  Determination of environmental pollutants in breast milk
• Другое 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
• Другое Continuous recording of the child's temperature for 7 days
  Continuous recording of the child\'s temperature for 7 days
• Другое Use of a sleep diary for 7 days
  Use of a sleep diary for 7 days
• Другое Parental questionnaire of environmental exposure
  Parental questionnaire of environmental exposure

Первичные конечные точки

• total sleep time per day in infants using actimetry [Срок оценки: 7 days]

Вторичные конечные точки (3)

• Concentration of various substances in breast milk [Срок оценки: 1 day]
• concentration of chemical polluants on newborn bracelets [Срок оценки: 1 day]
• Child Temperature level (°C) [Срок оценки: 7 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• CHRU Amiens — Amiens

Идентификаторы

NCT: NCT06268444 · PI2023_843_0077

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗