Actively Recruiting

Age: 0 - 17Years
All Genders
Healthy Volunteers
ID06754696

Evaluation of Blood Protein O-GlcNAcylation Levels in Children - CHANCE Study (Child Heart O-glcnAc Nantes)

Led by Nantes University Hospital · Updated on 2025-02-13

240

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Sepsis is a leading cause of death and disability in children worldwide, with a particularly high mortality rate in young children. This research aims to evaluate blood protein O-GlcNAcylation levels in children, a process shown in animal studies to improve cardiac function and survival during septic shock and other acute conditions. Understanding this process in children could lead to better management of septic shock and other systemic inflammatory responses in pediatric patients. The study observes two groups of children: healthy children undergoing routine blood tests for various medical reasons and children experiencing septic shock requiring intensive care and vascular filling. Blood samples will be collected at inclusion and multiple time points over 48 hours to measure O-GlcNAcylation levels and assess their relationship with septic shock severity. The study is observational and does not involve any investigational drug or treatment but collects clinical data from medical records. Participants will provide blood samples during their hospital visits or stays, with clinical data recorded in their medical files. Blood samples will be taken once or multiple times depending on the group and clinical need. Researchers will analyze O-GlcNAcylation levels at inclusion and compare them between healthy children and those in septic shock. Long-term follow-up of up to 5 years will assess links between these levels and patient prognosis. The study spans from 2025 to 2036, focusing on children from birth to 17 years old.

CONDITIONS

Brief Title

Evaluation of Blood Protein O-GlcNAcylation Levels in Children

Who Can Participate

Age: 0 - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 0 to 17 years at the time of sampling (including premature infants)
  • Children attending hospital for blood samples as part of pre-operative, allergy, or other non-sepsis related check-ups
  • Premature infants monitored with blood samples
  • Collection of umbilical cord blood
  • Signed consent provided
  • Children with suspected or diagnosed sepsis according to 2016 definition
  • Premature infants with suspected or diagnosed sepsis
  • Inclusion of all responsible bacteria, viruses, or fungi
  • Signed bio-collection consent
Not Eligible

You will not qualify if you...

  • Children with an infection (for healthy group)
  • Children with fever (for healthy group)
  • Children with immune deficiency
  • Children with autoimmune disease
  • Children with metabolic disease
  • Children with haematological diseases
  • Children with genetic disease
  • Unsigned consent or refusal by parents or child
  • Unsigned bio-collection consent or refusal (for septic group)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants undergo blood sampling during routine hospital visits to evaluate O-GlcNAcylation levels.

1 visit (in-person)

Monitoring

Duration - 48 hours

Participants in septic shock have multiple blood samples taken to monitor O-GlcNAcylation levels and clinical status over the first 48 hours.

6 visits within 48 hours (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants in septic shock are followed for up to 5 years to assess the relationship between O-GlcNAcylation levels and prognosis.

Follow-up visits as part of medical care

Trial Site Locations

Total: 1 location

1

Nantes University Hospital

Nantes, France, 44093

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Research Team

M

Manon Denis, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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