About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate in the research
Trial population
Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)
Trial design
Cohort
Prospective
Treatments tested in this trial
Clinical examination
Other interventionFor 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.
Treatment groups
Trial outcomes
Primary outcomes
Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory
: 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
Secondary outcomes
Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves)
Collect of the age at which children and adolescents begin to develop adult physical characteristics, such as breasts or pubic hair, and become able to procreate.
Other outcomes
Age at established puberty (period for girls, molting for boys)
Collect of the age at which girls had their period and boys molted
Plasma concentrations of steroid hormones
Blood collection for hormonal and organochlorine pollutants dosage.
Blood pressure
Seated resting blood pressure will be measured using an automatic tensiometer an automatic blood pressure monitor, with two measurements separated by 15 to 30 minutes.
heart rate
heart ratewill be measured using an automatic tensiometer an automatic blood pressure monitor, with two measurements separated by 15 to 30 minutes.
Sponsors and contacts
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Centre Hospitalier Universitaire de la Guadeloupe
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator