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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT02586961
Eligibility Criteria:
Inclusion Criteria:
* Infants aged 6 weeks to 12 months admitted in paediatric emergency
* First episode of acute bronchiolitis defined as: expiratory dyspnea with breath slowing and/or sibilants and/or crackles preceded by (or associated with) a nasopharyngitis more or less febrile
* Respiratory distress assessment index score (RDAI) of 4 to 15 after a nasopharyngeal clearance
* Agreement of at least one of the parents for his child to participate in biomedical research
* Affiliation to social security (beneficiary or entitled), except beneficiary of State medical help
Exclusion Criteria:
* Prematurity (less than 37 weeks of gestation)
* Antecedent of invasive respiratory ventilation during neonatal period
* Antecedent of lung or chronic cardiac pathology of wich rhythm disorder, acute obstructive cardiomyopathy and coronary insufficiency
* Immune deficiency
* Active viral infection (hepatitis, zona, herpes, varicella, HIV)
* Proven or suspected tuberculosis
* Exposure to varicella during 15 days before inclusion
* Severe distress (defined as one of following signs: a pulse rate \>200/min, respiratory rate \>80/min, RDAI score \>15, neurological disorders)
* Nebulization (aerosol spray) of Salbutamol or other bronchodilator treatment during the 24 hours before the inclusion
* Inhalation (spray) of Salbutamol during the preceding 24 hours
* Oral or inhaled corticosteroids during the preceding 2 weeks
* Previous episode of wheezing or ascertained diagnosis of asthma
* Hypersensitivity to one of the constituting of oral betamethasone
* Vaccination by living vaccine during the preceding 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Months
Study:
NCT02586961
Study Brief:
Protocol Section:
NCT02586961