Biomarker-s of Abusive Head Trauma by Proteomics

January 11, 2023 updated by: Kim Wiskott, University Hospital, Geneva

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infant between 0 to 2 y.o

Description

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..)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highlight novel biomarker-s of AHT
Time Frame: 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).
Hospital admission to discharge (up to 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Hospices Civils de Lyon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2028

Study Completion (Anticipated)

February 1, 2028

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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