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临床试验/NCT06653660
NCT06653660招募中不适用

Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe

Centre Hospitalier Universitaire de la Guadeloupe1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2022年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
650
试验地点
1
主要终点
Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory

研究概览

简要总结

In the context of environmental pollution of the French West Indies by chlordecone and questions about health consequences, monitoring at the peripubertal age of children born alive in the TIMOUN cohort is justified in several respects: - existence of an already established mother-child cohort whose live-born children will reach peripubertal ages during the period 2020-2022; - opportunity to verify hypotheses put forward on the basis of toxicological data acquired in laboratory animals and the hormonal characteristics of chlordecone (endocrine disruptor); - strong societal demand for such research to be carried out because of concerns about the sensitivity of children and adolescents to the effects of environmental xenobiotics, in particular on sexual development and the age of puberty; - recommendation of the Scientific Council Chlordecone Inserm - InVS; specific action of the National Plan Chlordecone IV.

详细描述

The French West Indies are permanently polluted by chlordecone. It is an organochlorine insecticide used from 1973 to 1993 in Guadeloupe and Martinique to control banana root borers. Its physico-chemical properties give it great stability and are at the origin of its persistence in the environment. Soil, flora and wildlife pollution from chlordecone in the Caribbean was first documented shortly after its introduction in 1973. However, it was not until 1999 that this pollution was extended to waters intended for human consumption and to various local, vegetable and animal, land and aquatic foodstuffs. The population is also affected, as confirmed by impregnation studies, with exposure nowadays occurring mainly through the consumption of contaminated food. The contamination of the French West Indies populations by this insecticide raises many questions about its possible health consequences. In order to assess the effects of chlordecone exposure on child development in Guadeloupian children, a longitudinal and prospective study, the Timoun mother-child cohort, was initiated. Between 2004 and 2007, women in the second trimester of pregnancy who planned to give birth in the public hospitals of Grande-Terre and Basse-Terre (accounting for 70% of all deliveries in Guadeloupe) were invited to participate in the study. Children born to these included women have been enrolled to several follow-ups during the last years (3, 7, 18 months and 7 years of age).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007) and whose parents agreed to be contacted later.
  • Residing in Guadeloupe at the peripubertal age
  • Affiliation to a social security scheme
  • Agreement to participate in the study and informed consent signed by the minor
  • Study participation agreement and informed consent signed by the parents

排除标准

  • Refusal to participate in the research

结局指标

主要结局

Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory

时间窗: At the start of the study (inclusion visit)

: Cognitive tests (25 min for the 3 Wechsler Intelligence Scale for Children V subscales). The Wechsler Intelligence Scale for Children-V is the most scientifically valid intelligence test for children and adolescents. It can be used to determine a child's or teenager's intelligence quotient (IQ), to obtain their complete cognitive profile and the level of the 5 main components of cognitive intelligence

次要结局

  • Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves)(At the start of the study (inclusion visit).)

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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