Biomarker-s of Abusive Head Trauma by Proteomics

NCT ID: NCT05626465

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2028-02-29

Brief Summary

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The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.

Detailed Description

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Conditions

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Abuse, Child Protein Disorder, Blood

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Abusive Head Trauma (AHT)

Blood test

Intervention Type OTHER

Proteomic analyses on serum

Accidental traumatic brain injury

Blood test

Intervention Type OTHER

Proteomic analyses on serum

Cranioplasty

Blood test

Intervention Type OTHER

Proteomic analyses on serum

Infant malaise without AHT

Blood test

Intervention Type OTHER

Proteomic analyses on serum

Interventions

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Blood test

Proteomic analyses on serum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age : 0-2 y.o
* Medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty
* Blood test during medical care
* Accepted informed consent

Exclusion Criteria

* Refused informed consent
* For control groups : medical history of child abuse
* For AHT group : rare metabolic disease (Menkes, etc..)
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Kim Wiskott

Dre Kim Wiskott

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tony Fracasso, Prof.

Role: STUDY_DIRECTOR

University Hospital, Geneva

Locations

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Ginhoux Thiphanie

Lyon, Rhône, France

Site Status

Wiskott Kim

Geneva, , Switzerland

Site Status

Countries

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France Switzerland

Central Contacts

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Kim Wiskott, MD

Role: CONTACT

0041797737424

Facility Contacts

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Thiphanie Ginhoux

Role: primary

+33(0)4 27 85 77 23

Kim Wiskott

Role: primary

Other Identifiers

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2021-01971

Identifier Type: -

Identifier Source: org_study_id

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