Biomarker-s of Abusive Head Trauma by Proteomics

Sponsor

University Hospital, Geneva (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05626465

Collaborator

Hospices Civils de Lyon (Other)

174

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abuse, Child Protein Disorder, Blood	Other: Blood test

Study Design

Study Type:

Observational

Anticipated Enrollment :

174 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2028

Anticipated Study Completion Date :

Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Abusive Head Trauma (AHT)	Other: Blood test Proteomic analyses on serum
Accidental traumatic brain injury	Other: Blood test Proteomic analyses on serum
Cranioplasty	Other: Blood test Proteomic analyses on serum
Infant malaise without AHT	Other: Blood test Proteomic analyses on serum

Outcome Measures

Primary Outcome Measures

Highlight novel biomarker-s of AHT [Hospital admission to discharge (up to 3 days)]
Proteomic analyses will be made on serum of infant victim of AHT. Results will be compare with control groups (traumatic brain injury, cranioplasty, malaise).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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..)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ginhoux Thiphanie	Lyon	Rhône	France	69677
2	Wiskott Kim	Geneva		Switzerland

Sponsors and Collaborators

University Hospital, Geneva
Hospices Civils de Lyon

Investigators

Study Director: Tony Fracasso, Prof., University Hospital, Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kim Wiskott, Dre Kim Wiskott, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT05626465

Other Study ID Numbers:

2021-01971

First Posted:

Nov 23, 2022

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kim Wiskott, Dre Kim Wiskott, University Hospital, Geneva

abusive head trauma

proteomic

biomarker

Additional relevant MeSH terms:

Craniocerebral Trauma

Blood Protein Disorders

Study Results

No Results Posted as of Jan 13, 2023