Biomarker-s of Abusive Head Trauma by Proteomics

Abuse, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05626465
• Other study ID #: 2021-01971
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: February 2028

Study information

• Verified date: January 2023
• Source: University Hospital, Geneva
• Contact: Kim Wiskott, MD
• Phone: 0041797737424
• Email: kim.wiskott[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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..)

Related Conditions & MeSH terms

• Abuse, Child
• Blood Protein Disorders
• Craniocerebral Trauma

Intervention

Other:
• Blood test
Proteomic analyses on serum

Locations

Country	Name	City	State
France	Ginhoux Thiphanie	Lyon	Rhône
Switzerland	Wiskott Kim	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highlight novel biomarker-s of AHT	Proteomic analyses will be made on serum of infant victim of AHT. Results will be compare with control groups (traumatic brain injury, cranioplasty, malaise).	Hospital admission to discharge (up to 3 days)