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Search / Trial NCT06946264

Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features

Launched by NEMOURS CHILDREN'S CLINIC · Apr 18, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Double Blind Randomized Clinical Trial

ClinConnect Summary

This clinical trial is studying how children with bronchiolitis respond to a common treatment called a bronchodilator, specifically albuterol. Bronchiolitis is a respiratory condition that primarily affects young children and can lead to breathing difficulties. While bronchodilators are often used for asthma, their effectiveness in treating bronchiolitis is unclear. Researchers want to understand if certain genetic factors or clinical characteristics can help predict which children will benefit from this treatment. The study will involve children aged 3 to 24 months who are diagnosed with bronchiolitis and visiting the emergency department.

Eligible participants will include children who are not premature or, if they are, do not have other health issues. They will receive a dose of albuterol or a placebo (which looks the same but doesn’t contain the active medication) and undergo assessments before and after the treatment. The study will also collect samples like blood and swabs to investigate genetic factors that might influence treatment response. Ultimately, this research aims to develop a better way to identify which children with bronchiolitis are likely to benefit from bronchodilator treatment, helping to improve care and reduce unnecessary treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Nemours Children's Clinic

Nemours Children's Clinic is a leading pediatric healthcare organization dedicated to enhancing the health and well-being of children through innovative clinical care, research, and education. As a prominent clinical trial sponsor, Nemours is committed to advancing pediatric medicine by conducting rigorous clinical trials that explore new treatments and therapies. The clinic's multidisciplinary team of experts collaborates closely with families and community partners to ensure that research initiatives are aligned with the unique needs of children. With a focus on safety, efficacy, and ethical standards, Nemours Children's Clinic aims to foster breakthroughs that will improve health outcomes for children and adolescents.

Locations

Orlando, Florida, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported