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

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ClinicalTrials.gov Identifier: NCT03371641
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : January 27, 2019
Estimated Study Completion Date : January 27, 2025

Arm Intervention/treatment
Alcoholic exposure group
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
ASQ parental questionnaire

Behavioral: Development scales
WPPSI - IV and NEPSY development scales

Behavioral: Scale of Conners
Scale of Conners

Behavioral: SCQ Questionnaire
SCQ questionnaire

Procedure: Blood sample (mother)
Blood sample (mother) before delivery

Procedure: Cord blood sample
Cord blood sample after delivery

Procedure: Placenta sample
Placenta sample

Control
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
ASQ parental questionnaire

Behavioral: Development scales
WPPSI - IV and NEPSY development scales

Behavioral: Scale of Conners
Scale of Conners

Behavioral: SCQ Questionnaire
SCQ questionnaire

Procedure: Blood sample (mother)
Blood sample (mother) before delivery

Procedure: Cord blood sample
Cord blood sample after delivery

Procedure: Placenta sample
Placenta sample




Primary Outcome Measures :
  1. PLGF concentrations in the umbilical cord [ Time Frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions ]
    Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.

  2. PLGF concentrations in placenta [ Time Frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions ]
    Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.


Secondary Outcome Measures :
  1. Assessment of the concentration of PLGF in maternal blood [ Time Frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions ]
    Blood sample

  2. Studies of metabolomic profile on blood sample [ Time Frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions ]
    blood sample metabolomic profile

  3. Studies of metabolomic profile on placenta [ Time Frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions ]
    placenta metabolomic profile

  4. Neurological clinical evaluation [ Time Frame: The day of birth ]
    Clinical exam

  5. Follow-up at 2 years in pediatric consultation for evaluation of neuro-development [ Time Frame: 2 years ]
    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.

  6. Follow-up at 6 years in consultation for assessment of neurodevelopment with [ Time Frame: 6 years ]
    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.

  7. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV [ Time Frame: 6 years ]
    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.

  8. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment [ Time Frame: 6 years ]
    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

  9. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale [ Time Frame: 6 years ]
    Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)

  10. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire [ Time Frame: 6 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371641


Contacts
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Contact: POURCHER 02 32 88 82 65 cecile.pourcher@chu-rouen.fr
Contact: BLOT 02 32 88 82 65 julien.blot@chu-rouen.fr

Locations
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France
UH ROUEN Recruiting
Rouen, France, 76000
Contact: POURCHER    02 32 88 82 65    cecile.pourcher@chu-rouen.fr   
Contact: BLOT    02 32 88 82 65    julien.blot@chu-rouen.fr   
Principal Investigator: MARRET         
Sponsors and Collaborators
University Hospital, Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03371641     History of Changes
Other Study ID Numbers: 2016/337/HP
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
Fetal Alcohol Syndrome
Pregnancy
Biomarker
PlGF
Cognitive development
Behavior troubles
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders