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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT04408534
Eligibility Criteria:
Inclusion Criteria:
* Children born at gestational age \> 36 weeks gestation
* Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
* Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia \< 80 / min, 2/Associated with desaturation \< 85% or 3/Duration more than 10 seconds
* Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)
Exclusion Criteria:
* With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
* Ventilated in NIV for more than 48 hours before inclusion
* Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
* Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
* Patient not affiliated to health care insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
6 Months
Study:
NCT04408534
Study Brief:
Protocol Section:
NCT04408534