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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04677556
Eligibility Criteria:
Inclusion Criteria:
* Clinical and radiological diagnosis of bronchiolitis
* Need for non-invasive ventilation support (NiPPV or CPAP) with a modified Wood clinical asthma score (m-WCAS)\> 4 and / or hypercapnic acidosis (pH \<7.3 and / or pCO2\> 50mmHg)
* Written parental informed consent
Exclusion Criteria:
* Contraindication to nasogastric tube (recent surgery of the esophagus, esophageal malformation at risk of perforation, severe coagulopathy)
* Absolute or relative contraindication to NIV
* Respiratory collapse: coma (GCS \<12) and / or more than 3 apneas per hour with bradycardia \<90 / min and / or SpO2 \<90%
* Pneumothorax
* Preexisting disorder that may influence WOB
* Neuromuscular disease
* Chronic respiratory failure already under NIV or tracheostomy at home
* No social security
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT04677556
Study Brief:
Protocol Section:
NCT04677556