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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03157102
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 6 months and \<18 years old
* Hospitalized in PICU with status asthmaticus defined by
1. a PRAM score \> 7 with no response at H2 to the conventional treatment according to the GINA (Global Initiative for Asthma guidelines) protocol: Oxygen therapy, Continuous nebulization of beta2 agonist for at least one hour then every hour, Oral or intravenous corticosteroid (ie methylprednisolone 2mg/kg/j)
2. or with hypercapnic acidosis (pCO2 \> 45 mmHg and pH \< 7,35)
* Informed consent signed by at least on parent or legal guardians prior to inclusion and oral consent of the other parent if absent
Exclusion Criteria:
* Non-corrected congenital heart disease, or neuromuscular disease, or chronic respiratory disease (pulmonary or bronchial fibrosis, cystic fibrosis), or ENA disease (laryngo or tracheo malacia), scoliosis or chronic metabolic disease
* Need for non-invasive or invasive ventilation (Glasgow comas scale \<8, hemodynamic instability, refractory hypoxemia, cardiac arrest)
* Pneumothorax confirmed on the X-ray
* No national health coverage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT03157102
Study Brief:
Protocol Section:
NCT03157102