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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT06722118
Eligibility Criteria:
Inclusion Criteria:
* Patients intubated with an endotracheal tube with or without a cuff,
* Aged from 2 days post-term to 6 years,
* On mechanical ventilation for at least 36 hours,
And meeting the following extubation criteria:
* Extubation planned by the medical team
* Fraction of inspired oxygen (FiO2) ≤ 45%,
* Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,
* Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
* Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.
* Affiliated with a social security system,
* Collection of informed consent from the parental authority, by both parents or the legal guardian(s).
Exclusion Criteria:
* Refusal of consent by at least one parent or by the legal guardian(s),
* Patient with a contraindication to IV-DXM:
* Uncontrolled local or general infection,
* Active viral infections (hepatitis, herpes, chickenpox, shingles),
* Live vaccines,
* Severe coagulation disorders,
* Ongoing gastrointestinal bleeding,
* Known hypersensitivity to IV-DXM or one of its excipients.
* Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,
* Patient receiving State Medical Aid,
* Patient on long-term NIV,
* Known upper airway pathology (UAP) before intubation or at the time of extubation,
* History of UAP surgery within the month preceding inclusion,
* Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,
* Decision to limit or stop therapeutic interventions.
* Premature patients aged less than 40 weeks of gestation
* Newborns aged less than 2 days after post-term birth
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
6 Years
Study:
NCT06722118
Study Brief:
Protocol Section:
NCT06722118