A Phase 4 interventional study of Placebos and Dexamethasone Oral in Bronchiolitis, Viral, sponsored by Allison Williams. Terminated at 1 site in United States. Open to participants aged 1 Day to 2 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Allison Williams · Phase 4, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 3 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →This is the only study on the registry with Allison Williams as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be given a placebo of sugar water (0.6ml/kg/dose) in a single oral dose and standard of care for bronchiolitis (supplemental oxygen, antipyretics, suctioning etc.)
Drug: Placebos
Participants will be given dexamethasone (0.6mg/kg/dose) in a single oral dose in addition to the standard of care for bronchiolitis (supplemental oxygen, antipyretics, suctioning etc.)
Drug: Dexamethasone Oral
Sugar water based on same ml dosing of intervention arm drug
Also known as: sugar water
0.6mg/kg/dose - single oral dose administration to intervention arm
Also known as: Decadron
Hospital Length of Stay
Measurement of hospital length of stay in hours
Time frame: Admission vitals through discharge paperwork printing time, average of 24-96 hours
Severity of Bronchiolitis
Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)
Time frame: Will obtain MTS upon admission by chart view or, if unable, at time of enrollment, and compare to MTS obtained 12 hours after medication administration
Severity of Bronchiolitis
Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)
Time frame: Will compare respiratory assessment via MTS 12 hours after admission and at discharge, average of 24-96 hours from admission
Severity of Bronchiolitis
Measurement of reducing severity of bronchiolitis by evaluation of patient outcome - discharge, transfer to ICU or acute care floor
Time frame: Admission to time of discharge to home or transfer to ICU or acute care floor, usual time frame is 24-72 hours
7-day Same-Cause Revisit Rate
Measuring number of revisits to the primary care physician or emergency room or re-admission to the hospital for ongoing bronchiolitis related symptoms within 7 days of discharge
Time frame: Discharge to 7 days
| Milestone | Placebo Arm | Dexamethasone Arm |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 0 |
| Not completed | 0 | 1 |
Measurement of hospital length of stay in hours
No measurements were reported for this outcome.
Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)
No measurements were reported for this outcome.
Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)
No measurements were reported for this outcome.
Measurement of reducing severity of bronchiolitis by evaluation of patient outcome - discharge, transfer to ICU or acute care floor
No measurements were reported for this outcome.
Measuring number of revisits to the primary care physician or emergency room or re-admission to the hospital for ongoing bronchiolitis related symptoms within 7 days of discharge
No measurements were reported for this outcome.
Collected over 12-36 hours (length of hospital admission). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Dexamethasone | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(months) | Placebo Arm | Dexamethasone Arm | Total |
|---|---|---|---|
| Mean | 2.75 ± 1.77 | 12 ± NA | 5.83 ± 5.48 |
| Sex: Female, Male(Participants) | Placebo Arm | Dexamethasone Arm | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 1 | 1 | 2 |
| Race and Ethnicity Not Collected(Participants) | Placebo Arm | Dexamethasone Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Dec 2022, 34 months.
Results were first posted in Mar 2023, 2 months after primary completion.
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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone