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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Stimulation of O-GlcNAcylation has been shown to be beneficial in several acute pathologies and different animal models, such as haemorrhagic and septic shock, and ischaemia-reperfusion (cerebral and cardiac). It could therefore be interesting to use this approach in children in order to limit the impact of various pathologies inducing SIRS, such as extracorporeal circulation for major surgery, septic shock or various traumas. The investigators demonstrated in 2 different animal models (endotoxemia by injection of Lipopolysaccharides and caecal puncture ligation model) with 3 different pharmacological molecules (Glucosamine, ThiametG and NButGT) that stimulation of O-GlcNAcylation was beneficial in the early phase of septic shock with a marked effect on cardiac function and survival. The investigators thus demonstrated that stimulation of O-GlcNAcylation was beneficial in young rats in septic shock. However, none of this work has yet been reproduced in humans, either children or adults.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: t
View:

⁃ 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

• 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

Locations
Other Locations
France
Nantes University Hospital
RECRUITING
Nantes
Contact Information
Primary
Manon Denis, MD
manon.denis-med@chu-nantes.fr
+33 2 40 08 34 83
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2036-01-31
Participants
Target number of participants: 240
Treatments
Healthy group
children attending hospital and receiving a blood sample as part of their care during general paediatric consultations, anaesthesia or day hospital consultations.~Children requiring a blood test as part of a medical indication in the first week of life / blood samples taken at birth from cord blood.~A blood sample will be taken at inclusion during a blood test carried out in the care unit, and possibly if other blood samples are planned as part of the care, additional samples will be taken in a maximum of 6 tubes in 48 hours, i.e. for a total volume of 600 µl to 3 ml. The child's clinical data will be collected in his medical file.
Septic shock
Children attending a paediatric emergency department for a severe infection requiring vascular filling, or a child admitted to an intensive care unit for sepsis or presenting with sepsis during hospitalisation.~A blood sample will be taken at inclusion during a blood test carried out in the care unit and then at H3, H6, H12, H24 and H48, i.e. 6 times in 48 hours for a total volume of 600 µl to 3 ml for patients in septic shock. The child's clinical data will be collected in his medical file.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov