Biomarker-s of Abusive Head Trauma by Proteomics

NCT05626465 — Not yet recruiting, 174 participants, University Hospital, Geneva

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

Registry	NCT05626465
Status	Not yet recruiting
Study type	Observational
Enrollment	174 (Estimated)
Sponsor	University Hospital, Geneva (Other); collaborators: Hospices Civils de Lyon
Conditions	Abuse, Child, Protein Disorder, Blood
Interventions	Blood test (Other)
Dates	start 2023-02-01 (estimated), primary completion 2028-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2022-11-23, last updated 2023-01-13
Locations	2 sites in France, Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Abusive Head Trauma (AHT)		Other: Blood test
Accidental traumatic brain injury		Other: Blood test
Cranioplasty		Other: Blood test
Infant malaise without AHT		Other: Blood test

Blood test (Other): Proteomic analyses on serum

+Outcome measures

Primary outcomes

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

Sex: All, ages: any to 2 Years, accepts healthy volunteers

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..)

+Locations (2)

Facility	City	Country	Status
Ginhoux Thiphanie	Lyon, Rhône	France
Wiskott Kim	Geneva	Switzerland

+Investigators

Tony Fracasso, Prof., Study director, University Hospital, Geneva