Fetal Alcohol SyndromeALCOBRAINNCT03371641
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
A study testing ASQ parental questionnaire, Development scales and Scale of Conners in people with Fetal Alcohol Syndrome, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Syndrome
- What is being tested?
- ASQ parental questionnaire, Development scales and Scale of Conners
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2017to 27 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH ROUEN
Rouen, 76000
POURCHER, 02 32 88 82 65, cecile.pourcher@chu-rouen.fr
BLOT, 02 32 88 82 65, julien.blot@chu-rouen.fr
About this study
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.
- Conditions
- Fetal Alcohol Syndrome
- Being tested
- ASQ parental questionnaire, Development scales, Scale of Conners, SCQ Questionnaire, Blood sample (mother)
- Keywords
- Fetal Alcohol Syndrome, Pregnancy, Biomarker, PlGF, Cognitive development, Behavior troubles
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASQ parental questionnaireBehavioural
ASQ parental questionnaire
Development scalesBehavioural
WPPSI - IV and NEPSY development scales
Scale of ConnersBehavioural
Scale of Conners
SCQ QuestionnaireBehavioural
SCQ questionnaire
Blood sample (mother)Procedure or surgery
Blood sample (mother) before delivery
Cord blood sampleProcedure or surgery
Cord blood sample after delivery
Placenta sampleProcedure or surgery
Placenta sample
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic exposure group | Other | Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire Receives: 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 |
| Control | Other | Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLGF concentrations in the umbilical cord
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
Measured: 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.
Measured: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary outcomes (10)
Assessment of the concentration of PLGF in maternal blood
Blood sample
Measured: 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
Measured: 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
Measured: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Neurological clinical evaluation
Clinical exam
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start27 Jan 2017
- Primary completion27 Mar 2026 (estimated)
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371641
- Sponsor's protocol ID
- 2016/0337/HP
- Acronym
- ALCOBRAIN
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
- ClinicalTrials.gov ID
- NCT03371641
- Acronym / sponsor ID
- ALCOBRAIN / 2016/0337/HP
- Conditions
- Fetal Alcohol Syndrome
- Keywords
- Fetal Alcohol Syndrome, Pregnancy, Biomarker, PlGF, Cognitive development, Behavior troubles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic exposure group | Other | Behavioral: ASQ parental questionnaire, Behavioral: Development scales, Behavioral: Scale of Conners, Behavioral: SCQ Questionnaire, Procedure: Blood sample (mother), Procedure: Cord blood sample, Procedure: Placenta sampleBlood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire |
| Control | Other | Behavioral: ASQ parental questionnaire, Behavioral: Development scales, Behavioral: Scale of Conners, Behavioral: SCQ Questionnaire, Procedure: Blood sample (mother), Procedure: Cord blood sample, Procedure: Placenta sampleBlood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASQ parental questionnaireASQ parental questionnaire | Behavioural | Alcoholic exposure group, Control |
| Development scalesWPPSI - IV and NEPSY development scales | Behavioural | Alcoholic exposure group, Control |
| Scale of ConnersScale of Conners | Behavioural | Alcoholic exposure group, Control |
| SCQ QuestionnaireSCQ questionnaire | Behavioural | Alcoholic exposure group, Control |
| Blood sample (mother)Blood sample (mother) before delivery | Procedure or surgery | Alcoholic exposure group, Control |
| Cord blood sampleCord blood sample after delivery | Procedure or surgery | Alcoholic exposure group, Control |
| Placenta samplePlacenta sample | Procedure or surgery | Alcoholic exposure group, Control |
Primary outcome
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.
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.
10 secondary outcomes
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
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
Studies of metabolomic profile on placenta
Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Neurological clinical evaluation
Time frame: The day of birth
Follow-up at 2 years in pediatric consultation for evaluation of neuro-development
Time frame: 2 years
Follow-up at 6 years in consultation for assessment of neurodevelopment with
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
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale
Time frame: 6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASQ parental questionnaire, Development scales and Scale of Conners in people with Fetal Alcohol Syndrome, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact POURCHER (02 32 88 82 65, cecile.pourcher@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLGF concentrations in the umbilical cord (time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.