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

Primary Purpose

Fetal Alcohol Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ASQ parental questionnaire
Development scales
Scale of Conners
SCQ Questionnaire
Blood sample (mother)
Cord blood sample
Placenta sample
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Alcohol Syndrome focused on measuring Fetal Alcohol Syndrome, Pregnancy, Biomarker, PlGF, Cognitive development, Behavior troubles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UH ROUENRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Alcoholic exposure group

Control

Arm Description

Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire

Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire

Outcomes

Primary Outcome Measures

PLGF concentrations in the umbilical cord
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
PLGF concentrations in placenta
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.

Secondary Outcome Measures

Assessment of the concentration of PLGF in maternal blood
Blood sample
Studies of metabolomic profile on blood sample
blood sample metabolomic profile
Studies of metabolomic profile on placenta
placenta metabolomic profile
Neurological clinical evaluation
Clinical exam
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.
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.
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.
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
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale
Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)
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.

Full Information

First Posted
November 29, 2017
Last Updated
December 12, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT03371641
Brief Title
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Acronym
ALCOBRAIN
Official Title
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
January 27, 2019 (Anticipated)
Study Completion Date
January 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome
Keywords
Fetal Alcohol Syndrome, Pregnancy, Biomarker, PlGF, Cognitive development, Behavior troubles

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcoholic exposure group
Arm Type
Other
Arm Description
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Arm Title
Control
Arm Type
Other
Arm Description
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Intervention Type
Behavioral
Intervention Name(s)
ASQ parental questionnaire
Intervention Description
ASQ parental questionnaire
Intervention Type
Behavioral
Intervention Name(s)
Development scales
Intervention Description
WPPSI - IV and NEPSY development scales
Intervention Type
Behavioral
Intervention Name(s)
Scale of Conners
Intervention Description
Scale of Conners
Intervention Type
Behavioral
Intervention Name(s)
SCQ Questionnaire
Intervention Description
SCQ questionnaire
Intervention Type
Procedure
Intervention Name(s)
Blood sample (mother)
Intervention Description
Blood sample (mother) before delivery
Intervention Type
Procedure
Intervention Name(s)
Cord blood sample
Intervention Description
Cord blood sample after delivery
Intervention Type
Procedure
Intervention Name(s)
Placenta sample
Intervention Description
Placenta sample
Primary Outcome Measure Information:
Title
PLGF concentrations in the umbilical cord
Description
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
Title
PLGF concentrations in placenta
Description
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
Secondary Outcome Measure Information:
Title
Assessment of the concentration of PLGF in maternal blood
Description
Blood sample
Time Frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Title
Studies of metabolomic profile on blood sample
Description
blood sample metabolomic profile
Time Frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Title
Studies of metabolomic profile on placenta
Description
placenta metabolomic profile
Time Frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Title
Neurological clinical evaluation
Description
Clinical exam
Time Frame
The day of birth
Title
Follow-up at 2 years in pediatric consultation for evaluation of neuro-development
Description
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
Title
Follow-up at 6 years in consultation for assessment of neurodevelopment with
Description
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
Title
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV
Description
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
Title
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment
Description
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
Title
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale
Description
Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)
Time Frame
6 years
Title
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
POURCHER
Phone
02 32 88 82 65
Email
cecile.pourcher@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BLOT
Phone
02 32 88 82 65
Email
julien.blot@chu-rouen.fr
Facility Information:
Facility Name
UH ROUEN
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
POURCHER
Phone
02 32 88 82 65
Email
cecile.pourcher@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
BLOT
Phone
02 32 88 82 65
Email
julien.blot@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
MARRET

12. IPD Sharing Statement

Plan to Share IPD
No

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

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