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:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT03976895
Eligibility Criteria:
Inclusion Criteria:
* Infant under 6 months
* Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
* With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
* m-WCAS score ≥ 3 and / or hypercapnic acidosis with pH \<7.35 and pCO2\> 50mmHg (6.7 kPa)
* Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file.
Exclusion Criteria:
* Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH \<7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2\> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
* Patient already positioned in the prone position before randomization
* Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
* Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
* Patient who is not affiliated (or does not benefit from) to a national social security system
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT03976895
Study Brief:
Protocol Section:
NCT03976895