In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

Fetal Alcohol Syndrome Clinical Trial

— ALCOBRAIN  

Official title:

In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03371641
• Other study ID #: 2016/337/HP
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2017
• Last updated: December 12, 2017
• Start date: January 27, 2017
• Est. completion date: January 27, 2025

Study information

• Verified date: December 2017
• Source: University Hospital, Rouen
• Contact: POURCHER
• Phone: 02 32 88 82 65
• Email: cecile.pourcher[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Mother:

• Pregnant woman (monofetal or twin pregnancy, whatever the parity)

• Age> or = to 18 years

• Person affiliated to a social security system

• Person who read and understood the information form and signed the consent form

• Alcohol exposure group Chronic consumption of at least 30 g of alcohol per week or acute consumption of "binge drinking" type during pregnancy (knowing that a unit of 10 g of pure alcohol corresponds to 25 cl of beer 4 ° 5, 10 cl of wine at 12 °, 3 cl of whiskey, 7 cl of Porto ...)

• Control group No alcohol consumption during pregnancy

• Child Informed parents and written consent signed by the father and mother for the child's participation in this research (unless one of the parents does not have parental authority)

Exclusion Criteria:

• Female under 18

• Pregnant woman with clinical suspicion of pre-eclampsia and / or HELLP syndrome

• Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)

• Patient participating in another interventional trial or who participated in another interventional trial during pregnancy

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome

Intervention

Behavioral:
• ASQ parental questionnaire
ASQ parental questionnaire
• Development scales
WPPSI - IV and NEPSY development scales
• Scale of Conners
Scale of Conners
• SCQ Questionnaire
SCQ questionnaire

Procedure:
• Blood sample (mother)
Blood sample (mother) before delivery
• Cord blood sample
Cord blood sample after delivery
• Placenta sample
Placenta sample

Locations

Country	Name	City	State
France	UH ROUEN	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLGF concentrations in the umbilical cord	Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Primary	PLGF concentrations in placenta	Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary	Assessment of the concentration of PLGF in maternal blood	Blood sample	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary	Studies of metabolomic profile on blood sample	blood sample metabolomic profile	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary	Studies of metabolomic profile on placenta	placenta metabolomic profile	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary	Neurological clinical evaluation	Clinical exam	The day of birth
Secondary	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.	2 years
Secondary	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.	6 years
Secondary	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.	6 years
Secondary	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	6 years
Secondary	Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale	Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)	6 years
Secondary	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.	6 years