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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-22
SponsorCentre Hospitalier Universitaire de la Guadeloupe

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical examination

    Other intervention

    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.

Treatment groups

650 Participants
are divided into 1 treatment group
Group A: peripubertal children1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At the start of the study (inclusion visit)

Secondary outcomes

1

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.

Time frame
At the start of the study (inclusion visit).

Other outcomes

1

Age at established puberty (period for girls, molting for boys)

Collect of the age at which girls had their period and boys molted

Time frame
At the start of the study (inclusion visit) or through study completion, an average of two years, for girls who had their period and boys molted.
2

Plasma concentrations of steroid hormones

Blood collection for hormonal and organochlorine pollutants dosage.

Time frame
At the start of the study (inclusion visit).
3

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.

Time frame
At the start of the study (inclusion visit).
4

heart rate

heart ratewill be measured using an automatic tensiometer an automatic blood pressure monitor, with two measurements separated by 15 to 30 minutes.

Time frame
At the start of the study (inclusion visit).

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