Status:
RECRUITING
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Bronchiolitis
Bronchodilator Agents
Eligibility:
All Genders
3-24 years
Phase:
PHASE3
Brief Summary
Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in b...
Eligibility Criteria
Inclusion
- Children between 3 to 24 months of age
- Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower respiratory tract symptoms
- Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities
- Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)
Exclusion
- Patients previously enrolled in the PI's K12 study
- Documented history of asthma or reactive airway disease
- Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, neurologic condition)
- Diagnosis of pneumonia by chest radiography
- Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation
- Inhaled, nebulized, or oral bronchodilator administration within 4 hours of ED arrival
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06946264
Start Date
July 8 2022
End Date
December 31 2030
Last Update
April 27 2025
Active Locations (1)
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1
Nemours Children's Health
Orlando, Florida, United States, 32827