Evaluating blood protein levels in children with sepsis
Evaluation of Blood Protein O-GlcNAcylation Levels in Children - CHANCE Study (Child Heart O-glcnAc Nantes)
Nantes University Hospital · NCT06754696
This study is testing the levels of a specific protein change in the blood of children with sepsis to see if it can help improve their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06754696 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the levels of O-GlcNAcylation in blood proteins among children, particularly focusing on those with suspected or diagnosed sepsis. The research builds on previous animal studies that indicated potential benefits of stimulating O-GlcNAcylation in improving cardiac function and survival during septic shock. By examining both healthy children and those with sepsis, the study seeks to understand the role of this modification in pediatric septic conditions. The findings could provide insights into tailored therapeutic approaches for managing sepsis in children.
Who should consider this trial
Good fit: Ideal candidates include children aged 0 to 17 years, both healthy and those with suspected or diagnosed sepsis.
Not a fit: Patients with infections, fever, immune deficiencies, autoimmune diseases, metabolic diseases, hematological diseases, or genetic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for pediatric sepsis, potentially reducing mortality and morbidity.
How similar studies have performed: While previous studies have shown success in animal models, this approach has not yet been tested in human subjects.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Healthy group Inclusion Criteria : * Age from 0 to 17 years at the time of sampling (including premature infants) * Children coming to hospital for a blood sample to be taken as part of a pre-operative check-up, an allergy check-up or a check-up as part of a pathology other than sepsis. * Premature infants benefiting from a blood sample as part of their monitoring and management of prematurity * Collection of umbilical cord blood * Signed consent Exclusion Criteria : * Children with an infection * Children with fever * Children with an immune deficiency * Children with autoimmune disease * Children with metabolic disease * Children with haematological diseases * Children with a genetic disease * Unsigned consent * Refusal by parents or child 2. Septic group Inclusion Criteria : * Age from 0 to 17 years at the time of sampling (including preterm infants) * Children with suspected sepsis or diagnosed sepsis according to the 2016 definition * Premature infants having blood drawn for suspected or diagnosed sepsis * All responsible bacteria, viruses or fungi * Signed bio-collection consent Exclusion Criteria : * Children with an immune deficiency * Children with autoimmune disease * Children with a metabolic disease * Children with haematological diseases * Children with a genetic disease * Unsigned bio-collection consent * Refusal by parents or child
Where this trial is running
Nantes
- Nantes University Hospital — Nantes, France (RECRUITING)
Study contacts
- Study coordinator: Manon Denis, MD
- Email: manon.denis-med@chu-nantes.fr
- Phone: +33 2 40 08 34 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, Development and Health, Metabolism Changes, O-GlcNAcylation, Septic shock, metabolism, children