Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04438460
Eligibility Criteria:
Inclusion Criteria:
Patient Group:
* 1 month \< Age \< 12 years
* Multiple organ dysfunction within 48 hours following intensive care unit admission
* Beneficiary of a social security scheme.
* Consent signed by at least one parent / holder of parental authority
Control Group:
* 1 month \< Age \< 12 years
* Hospitalized for simple elective surgery
* Beneficiary of a social security scheme.
* Consent signed by at least one parent / holder of parental authority
Exclusion Criteria:
Patient Group:
* Weight \< 5 kg
* Known immunosuppression
* Prolonged corticotherapy
* Chronic inflammatory disease
* Malignant pathology with ongoing treatment
* Hepatic cirrhosis
* Polymerase Chain Reaction (PCR) Severe acute respiratory syndrome coronavirus (SARS-CoV-2) positive or patient with Pediatric Inflammatory Multisystem Syndrome (PIMS)
* Pediatric inflammatory multisystem syndrome (PIMS)
Control Group:
* Weight \< 5 kg
* Known immunosuppression
* Prolonged corticotherapy
* Chronic inflammatory disease
* Malignant pathology with ongoing treatment
* Ongoing infection
* Organ failure
* Hepatic cirrhosis
* PCR SARS-CoV-2 positive or patient with Pediatric Inflammatory Multisystem Syndrome (PIMS)
* Pediatric inflammatory multisystem syndrome (PIMS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Years
Study:
NCT04438460
Study Brief:
Protocol Section:
NCT04438460