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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT06848218
Eligibility Criteria:
Target population : Children aged 0 to 17, hospitalized in the pediatric intensive care unit for respiratory failure with indication for NIV.
Inclusion Criteria:
* Children aged 0 to 17 inclusive
* Children hospitalized in pediatric intensive care unit
* Indication for NIV
Exclusion Criteria:
* \- Severe deafness
* Clinical condition requiring immediate initiation of NIV
* Refusal to allow the child to be photographed
* Child not assessable by FLACC score (paralysis of lower limbs, etc.)
* Child already receiving NIV respiratory support at home
* Participation in other ongoing research involving the human person at major risk and constraint (RIPH category 1) or a drug trial according to European regulation 536/2014.
* Absence of affiliation to a French social security scheme or beneficiary of such a scheme.
* Subject deprived of liberty (art.L. 1121-6 du CSP)
* Failure to obtain free and informed written or oral consent and authorization to take photographs from both parents (or from a single parent if the patient is accompanied by only one parent, in accordance with article 1122-2 of the French Public Health Code) or from the legal guardian and/or child.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT06848218
Study Brief:
Protocol Section:
NCT06848218