Status:
WITHDRAWN
The Bronchiolitis in Hospitalized Infants Study
Lead Sponsor:
IDeA States Pediatric Clinical Trials Network
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Nebraska
Conditions:
Bronchiolitis
Eligibility:
All Genders
Up to 24 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to determine whether it is possible to identify, enroll, and deliver the study intervention (the corticosteroid dexamethasone) in hospitalized infants with bronchiol...
Detailed Description
This is a open-label single-arm pilot study to assess feasibility of study procedures. The study population is infants \<24 months of age, admitted with a physician diagnosis of non-RSV bronchiolitis ...
Eligibility Criteria
Inclusion
- Infants \<24 months of age at time of enrollment
- Admitted to the hospitalist service with a diagnosis of bronchiolitis
- RSV and COVID-19 Negative
- At least one of the following clinical criteria:
- personal history of breathing problems
- personal history of eczema
- parental history of asthma
- Parental ability to speak and read English or Spanish
Exclusion
- Preterm Infant (born at \< 34 weeks' gestation)
- Diagnosis of asthma
- Known underlying heart failure, hypertension, gastrointestinal bleeding, liver disease, thyroid disease (per parental report and chart review)
- Currently taking corticosteroids (inhaled or oral) or have taken corticosteroids within 7 days prior to hospitalization (per parental report and chart review)
- Admission to the intensive care unit (ICU) at time of enrollment
- Participants (caregivers) who, in the view of the investigator, whom are unlikely able to comply with the protocol requirements
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05994183
Start Date
October 9 2023
End Date
April 14 2025
Last Update
September 14 2023
Active Locations (2)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198