Bronchiolitis, ViralPhase 4NCT04221087
Steroid Use in Non-RSV Bronchiolitis
A Phase 4 study testing Dexamethasone Oral in people with Bronchiolitis, Viral, run by Allison Williams at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to 24 months
- First episode of wheezing or first clinical diagnosis of bronchiolitis
- Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh
- Ability of a parent or guardian to understand and comply with the study procedures
- Signed written informed consent by parent or guardian
Who cannot join
- Preterm birth < 35 weeks
- Presence of underlying cardiopulmonary, neuromuscular, or other complex disease
- Admission to the pediatric intensive care unit
- Co-infection with influenza infection or concomitant bacterial infection (such as pneumonia or AOM)
- History of allergy or reaction to steroids
- History of an underlying chronic medical condition -including chronic heart disease, chronic lung disease (except asthma),congenital anomalies of the airways or lung, cystic fibrosis, chronic renal disease including nephrotic syndrome, protein losing enteropathy of any cause, severe malnutrition, neurocognitive disorders, metabolic disorders (including phenylketonuria), or genetic disorders (note: genetic syndromes such as Down syndrome and Edwards Syndrome are excluded; however, children with genetic disorders (e.g., hemophilia) but who do not have a genetic syndrome may not satisfy this particular exclusion criterion; it is important that children with such genetic disorders do not have symptoms and/or comorbidities that would pose additional risk to them nor jeopardize the adequacy of study assessments.")
- History of a condition that compromises the immune system - human immunodeficiency virus infection, primary immunodeficiency, anatomic or functional asplenia; receipt of a hematopoietic stem cell or solid organ transplant at any time; receipt of immunosuppressive therapy including chemotherapeutic agents, biologic agents, antimetabolites or radiation therapy during the past 12 months; or daily use of systemic corticosteroids for more than 7 consecutive days during the past 14 days.
- Any other condition that in the judgment of the investigator precludes participation because it could affect the safety of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis
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.
Read the 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
- Being tested
- Placebos, Dexamethasone Oral
- Keywords
- bronchiolitis, non-RSV bronchiolitis, dexamethasone, treatment, steroid
- Medical subject headings
- Bronchiolitis, Viral, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Also called sugar water
Sugar water based on same ml dosing of intervention arm drug
Dexamethasone OralDrug
Also called Decadron
0.6mg/kg/dose - single oral dose administration to intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | 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.) Receives: Drug: Placebos |
| Dexamethasone Arm | Experimental | 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.) Receives: Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Measurement of hospital length of stay in hours
Measured: Admission vitals through discharge paperwork printing time, average of 24-96 hours
Secondary outcomes (4)
Severity of Bronchiolitis
Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)
Measured: 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)
Measured: 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
Measured: 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
Measured: Discharge to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start3 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: COVID19-pandemic, RSV surge
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either intervention or control group upon admission if they meet inclusion/exclusion criteria and consent.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allison Williams
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor-investigator, Allison Williams, University of Pittsburgh
- Investigators
- Allison E Williams, MD, Principal investigator, University of Pittsbrgh, UPMC Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221087
- Sponsor's protocol ID
- STUDY19080287
- Status last verified
- Mar 2023
- First submitted
- 29 Dec 2019
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Use for the Treatment of Non-RSV Bronchiolitis
- ClinicalTrials.gov ID
- NCT04221087
- Acronym / sponsor ID
- STUDY19080287
- Conditions
- Bronchiolitis, Viral
- Keywords
- bronchiolitis, non-RSV bronchiolitis, dexamethasone, treatment, steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19-pandemic, RSV surge
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Allison WilliamsUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either intervention or control group upon admission if they meet inclusion/exclusion criteria and consent.
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: PlacebosParticipants 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.) |
| Dexamethasone Arm | Experimental | Drug: Dexamethasone OralParticipants 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.) |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Less than or equal to 24 months
- First episode of wheezing or first clinical diagnosis of bronchiolitis
- Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh
- Ability of a parent or guardian to understand and comply with the study procedures
- Signed written informed consent by parent or guardian
Key exclusion criteria (8 listed)
- Preterm birth < 35 weeks
- Presence of underlying cardiopulmonary, neuromuscular, or other complex disease
- Admission to the pediatric intensive care unit
- Co-infection with influenza infection or concomitant bacterial infection (such as pneumonia or AOM)
- History of allergy or reaction to steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosAlso: sugar waterSugar water based on same ml dosing of intervention arm drug | Drug | Placebo Arm |
| Dexamethasone OralAlso: Decadron0.6mg/kg/dose - single oral dose administration to intervention arm | Drug | Dexamethasone Arm |
Primary outcome
Hospital Length of Stay
Time frame: Admission vitals through discharge paperwork printing time, average of 24-96 hours
Measurement of hospital length of stay in hours
4 secondary outcomes
Severity of Bronchiolitis
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
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
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
Time frame: Discharge to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison E Williams, MD principal investigator
University of Pittsbrgh, UPMC Children's Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Oral in people with Bronchiolitis, Viral, run by Allison Williams at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: Admission vitals through discharge paperwork printing time, average of 24-96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.