The Bronchiolitis in Hospitalized Infants Study (NCT05994183) | Clinical Trial Compass
WithdrawnEarly Phase 1
The Bronchiolitis in Hospitalized Infants Study
Stopped: The study was withdrawn with no participants enrolled due to the need for an IND from the FDA, which significantly expanded the scope of the study beyond what was originally anticipated for a pilot project within this network.
United States0Started 2023-10-09
Plain-language 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 bronchiolitis.
Participants in this study will be given two doses of dexamethasone within 72 hours of enrollment, followed by 30 days of safety monitoring.
Results of this feasibility pilot study may be used to inform the design of a future randomized controlled trial, whose results in turn could induce a paradigm shift in acute management of bronchiolitis.
Who can participate
Age range
0 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that receive 2 doses of dexamethasone per protocol.
Timeframe: Intervention: 72 hours; Follow-up: 30 days
Trial details
NCT IDNCT05994183
SponsorIDeA States Pediatric Clinical Trials Network