Assessing the impact of national guidelines on the management of children hospitalized for acute bronchiolitis.
Russell J McCulloh, Sarah E Smitherman, Kristin L Koehn...
https://pubmed.ncbi.nlm.nih.gov/23868897Actively Recruiting
Phase 3
Age: 3Months - 24Months
All Genders
ID06946264
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
Led by Nemours Children's Clinic · Updated on 2026-05-08
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bronchiolitis is a common cause of illness in young children, leading to significant healthcare use. This research aims to understand how children with bronchiolitis respond to bronchodilator treatments like albuterol, focusing on differences in clinical features and genetics. The study explores whether certain genetic variants and physical signs linked to allergic tendencies can predict how well a child with bronchiolitis responds to bronchodilators. Children aged 3 to 24 months diagnosed with bronchiolitis will be randomly assigned to receive either a nebulized dose of albuterol sulfate or a placebo solution (normal saline). This is a double-blind trial, meaning neither the participants nor the researchers know which treatment is given until after the study. The treatments will be prepared and stored securely in the emergency department. Participants will have their respiratory status assessed before and after the treatment. Researchers will collect samples including blood, urine, DNA from cheek swabs, and nasal swabs to study genetic and clinical responses. The main outcomes measured are changes in respiratory scores immediately after treatment and the relationship between genetic markers and bronchodilator response over about one year. The goal is to develop a prediction model combining clinical and genetic information to better identify children who may benefit from bronchodilator therapy.
CONDITIONS
Brief Title
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
Who Can Participate
Age: 3Months - 24Months
All Genders
Eligibility Criteria
You may qualify if you...
- 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 visit to seek care at Nemours Children's Health-Florida
You will not qualify if you...
- Patients previously enrolled in the PI's K12 study
- Documented history of asthma or reactive airway disease
- Co-morbidities affecting airway response such as chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, or neurologic condition
- Diagnosis of pneumonia by chest radiography
- Use of inhaled, nebulized, or oral corticosteroids within 72 hours of emergency department evaluation
- Use of inhaled, nebulized, or oral bronchodilators within 4 hours of emergency department arrival
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single administration during the emergency department visit
Participants receive a nebulized inhalation solution of either albuterol sulfate or sodium chloride as part of the randomized treatment.
1 treatment visit (in-person)
Follow-up
Duration - Up to 1 year after treatment
Participants are monitored for clinical response and genetic outcomes after the treatment.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Nemours Children's Health
Orlando, Florida, United States, 32827
Actively Recruiting
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Research Team
A
Andrea Rivera-Sepulveda, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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D F Willson, S D Horn, J O Hendley...
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Robert J Willer, Eric R Coon, Wade N Harrison...
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