An interventional study of Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment) and Extraction of microRNAs extracted from bucal swabs (act added for research). in Fetal Alcohol Spectrum Disorders, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in France. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific "epigenetic signature" for Fetal Alcohol Spectrum Disorder, in order to provide early diagnostic markers, determine the origin of the microRNAs identified and study the phenotypic-epigenetic relationship (microRNAs).
This research is descriptive and monocentric.
For the 18 patients in the Fetal Alcohol Spectrum Disorder group, the doctor will take a blood sample (for genetic testing) during a scheduled consultation. A remaining 4 ml of blood will be collected for research purposes (Fetal Alcohol Spectrum Disorder group only). A buccal smear will also be taken for research.
For the 18 participants in the control group (healthy participants of the same age and sex as the Fetal Alcohol Spectrum Disorder group), only a buccal smear will be taken for research purposes during a consultation.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's enrollment of 188 is above the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 137 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fetal Alcohol Spectrum Disorder group :
Control group :
Exclusion Criteria:
Fetal Alcohol Spectrum Disorder group :
Control group :
- people who are not matched on the age and sex of the Fetal Alcohol Spectrum Disorder patients sampled
Patients with Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive.
Diagnostic Test: Extraction of microRNAs extracted from plasma (4 ml recovered as part of treatment) · Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research).
Participants without Fetal Alcohol Spectrum Disorder, male an female, aged 0 to 18 inclusive.
Diagnostic Test: Extraction of microRNAs extracted from bucal swabs (act added for research).
Comparison of these micro RNAs with the micro RNAs extracted from oral swabs (in Fetal Alcohol Spectrum Disorder group)
Comparison of the microRNAs extracted from the oral swabs of the Fetal Alcohol Spectrum Disorder group with the microRNAs extracted from the oral swabs of the without Fetal Alcohol Spectrum Disorder group
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part 1)
Description of : * maternal alcohol consumption in the prenatal period and paternal alcohol consumption in the preconception period : * duration (in month) * type (Beer, wine, strong alcohol, Multiple) * frequency (DAILY/ WEEK/ WEEKEND/ FESTIVAL-OCCASIONAL/ SINGLE EPISODE ) * stage of exposure (Trimester : 1/2/ ≤ 2 /3/≤ 3) * other associated toxicants : tobacco, cannabis, medications (Yes/ no/ suspicion) * the course of the pregnancy and childbirth : * age of the mother (in years) * term of delivery (FULL-TERM/ MEDIUM PREMATURITY/ HIGH PREMATURITY/ VERY HIGH PREMATURITY) * trimester of discovery of the pregnancy (trimester : 1, 2, 3) * socio-family data * family situation (ADOPTION/ MOTHER/ PARENTS/ FATHER) * type of placement (FOSTER FAMILY/ HOME/ ADOPTIVE FAMILY/ THIRD PARTY/ NURSERY) * age of placement (in years)
Time frame: 6 months
Clinical description of a series of Fetal Alcohol Spectrum Disorder patients from Reunion Island (part2)
Description of : * data from the medical and genetic assessment * congenital malformations (Yes/ No) * hearing assessment (Normal/ abnormal), * Chromosome analysis on a DNA chip (Normal/ abnormal), * fragile X (Normal/ abnormal) * data from the neuropsychological and psychomotor assessment * psychomotor delay (Yes/ No) * motor impairments (Yes/ No) * intellectual disability (Yes/ No) (IQ Value) * cognitive impairments (VERY WEAK/ LIMITED/ MEDIUM WEAK/ MEDIUM/ MEDIUM STRONG/ SUPERIOR/ VERY SUPERIOR) * oral language, executive functions, behavioral abnormalities (alter/preserve), * data from paraclinical examinations : * kidney ultrasound, cardiac ultrasound, Magnetic Resonance Imaging (Nomal/ Abnormal)
Time frame: 6 months
Plan to share: No
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Fetal Alcohol Spectrum Disorders→
Centre Hospitalier Universitaire de la Réunion