Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical examination.
- Who it may be relevant to
- Registry conditions: Prenatal Exposure, Postnatal Exposure. Basic parameters: 16 years — 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guadeloupe
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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).
Interventions
- Other Clinical examination
For the aim of the present study, we will follow-up children born alive in the TIMOUN cohort at peripubertal age. Questionnaires will be administered to parents on the child's health and lifestyle. Stature-weight anthropometric and cardio-dynamic measurements of the child will be obtained. Scores on three cognitive tests will be obtained. Furthermore, steroid hormones and chlordecone in the child's peripheral blood will be determined.
Primary outcome measures
- Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory [Time frame: At the start of the study (inclusion visit)]
Secondary outcome measures (1)
- Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves) [Time frame: At the start of the study (inclusion visit).]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Refusal to participate in the research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Guadeloupe · 1 center
- CHU of Guadeloupe — Pointe-à-Pitre
Identifiers
NCT: NCT06653660 · PAP_RI2_2019/11