NCT04221087

Steroid Use in Non-RSV Bronchiolitis

Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Allison Williams · Academic / Other
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is a pilot randomized control trial to determine the efficacy of dexamethasone use in hospitalized children who are less than 2 years of age with non-respiratory syncytial virus (RSV) bronchiolitis admitted to the University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh from February 1 to May 31, 2022. It is hypothesized that the use of standard airway-dose steroids (0.6mg/kg dexamethasone) will improve the clinical outcome of children hospitalized for non-RSV bronchiolitis, which will be evident by decreased length of stay.

Detailed description

The study will take place at UPMC Children's Hospital of Pittsburgh with patients admitted to the general pediatric service. The attending physician on the clinical service team will identify patients diagnosed with bronchiolitis. If the participant meets inclusion and exclusion criteria, a member from the study team will then meet with the participant's family to discuss the study and obtained informed consent. A participant may have had a rapid RSV/influenza testing already complete for clinical purposes. If this has been done, participants will be asked to obtain a secondary nasopharyngeal swab so that it may be tested for a full respiratory viral panel for statistical stratification. Once rapid testing is obtained and results are negative for both RSV and influenza, the participant will then be randomized to either the intervention (dexamethasone) or control (placebo) arm of the study. Study members will calculate a modified Tal score (MTS) at time of consent and then 12-24 hours after medication administration. Throughout admission, participants will also receive standard of care for bronchiolitis, which may include regular vital sign evaluation, supplemental oxygen, intravenous fluids or nasogastric tube feedings, and anti-pyretic therapy. Because this is a pilot study, the study will be underpowered, however, this study will provide data that will allow the investigators to estimate the sample size needed for a future study. The number of time points to be used for the generalized estimating equation can be determined ad hoc to include a reasonably balanced sample to make the comparison valid.

Conditions

• Bronchiolitis, Viral

Interventions

Type	Name	Description
DRUG	Placebos	Sugar water based on same ml dosing of intervention arm drug
DRUG	Dexamethasone Oral	0.6mg/kg/dose - single oral dose administration to intervention arm

Timeline

• Start date: 2020-02-03
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-01-09
• Last updated: 2023-03-21
• Results posted: 2023-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study