NCT05626465

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2023Feb 2028

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

November 15, 2022

Last Update Submit

January 11, 2023

Conditions

Abuse, ChildProtein Disorder, Blood

Keywords

abusive head traumaproteomicbiomarker

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (4)

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

Interventions

Blood testOTHER

Proteomic analyses on serum

Abusive Head Trauma (AHT)Accidental traumatic brain injuryCranioplastyInfant malaise without AHT

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infant between 0 to 2 y.o

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ginhoux Thiphanie

Lyon, Rhône, 69677, France

Location

Wiskott Kim

Geneva, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Blood Protein Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Tony Fracasso, Prof.

    University Hospital, Geneva

    STUDY DIRECTOR

Central Study Contacts

Kim Wiskott, MD

CONTACT

0041797737424kim.wiskott@hcuge.ch

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dre Kim Wiskott

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)CH(1)