An interventional study of ASQ parental questionnaire and Development scales in Fetal Alcohol Syndrome, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic
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This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.
65 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's planned enrollment of 60 is below the median of 74 across 57 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Mother:
Person who read and understood the information form and signed the consent form
Exclusion Criteria:
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Behavioral: ASQ parental questionnaire · Behavioral: Development scales · Behavioral: Scale of Conners · Behavioral: SCQ Questionnaire · Procedure: Blood sample (mother) · Procedure: Cord blood sample · Procedure: Placenta sample
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Behavioral: ASQ parental questionnaire · Behavioral: Development scales · Behavioral: Scale of Conners · Behavioral: SCQ Questionnaire · Procedure: Blood sample (mother) · Procedure: Cord blood sample · Procedure: Placenta sample
ASQ parental questionnaire
WPPSI - IV and NEPSY development scales
Scale of Conners
SCQ questionnaire
Blood sample (mother) before delivery
Cord blood sample after delivery
Placenta sample
PLGF concentrations in the umbilical cord
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
PLGF concentrations in placenta
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Assessment of the concentration of PLGF in maternal blood
Blood sample
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Studies of metabolomic profile on blood sample
blood sample metabolomic profile
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Studies of metabolomic profile on placenta
placenta metabolomic profile
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Neurological clinical evaluation
Clinical exam
Time frame: The day of birth
Follow-up at 2 years in pediatric consultation for evaluation of neuro-development
ASQ: Ages \& Stages Questionnaires. This questionnaire screens and assesses the developmental performance of children in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. It is used to identify children that would benefit from in-depth evaluation for developmental delays.
Time frame: 2 years
Follow-up at 6 years in consultation for assessment of neurodevelopment with
parental ASQ: Ages \& Stages Questionnaire screens and assesses the developmental performance of children in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. It is used to identify children that would benefit from in-depth evaluation for developmental delays.
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV
WPPSI - IV: The Wechsler Preschool and Primary Scale of Intelligence consist of 14 subtests. They are designated as one of three types: core, supplemental, or optional. The core subtests are required for the computation of the Verbal, Performance, and Full Scale IQ. The supplemental subtests provide additional information about cognitive abilities or can be used as replacement for inappropriate subtests. The optional subtests provide additional information about cognitive functioning but cannot be used as replacements for core subtests. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.elow 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment
NEPSY -NEuroPSYchological Assessment. The six functional domains are made up of 32 subtests and four delayed tasks. These domains are theoretically, not statistically, derived. The subtests were designed to assess cognitive abilities related to disorders that are typically diagnosed in childhood and that are required for success in an academic environment. These tests supposedly help detect any underlying deficiencies that may impede a child's learning
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale
Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire
SCQ: The Social Communication is a 40 item, parent report screening measure that taps the symptomatology associaed with autism Spectrum disorder (ASD). The items are administered in a yes/non response format.
Time frame: 6 years
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2017 (actual). Primary completion is estimated for Mar 2026, 110 months after the start.
Of 28 interventional studies with no phase under Fetal Alcohol Spectrum Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 110 months is above that.
How these figures are worked out, and which studies are left out of them.
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