BronchiolitisEarly Phase 1BroncHINCT05994183
The Bronchiolitis in Hospitalized Infants Study
A Early Phase 1 study testing Dexamethasone Oral in people with Bronchiolitis, run by IDeA States Pediatric Clinical Trials Network at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2023to 14 Apr 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 0 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: The Bronchiolitis in Hospitalized Infants (BroncHI) Study: A Feasibility Trial Aimed to Identify and Treat Hospitalized Infants With Bronchiolitis Most at Risk for Recurrent Wheezing and Asthma
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.
Read the 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 that meet at least one of the following criteria: 1) history of breathing problems, 2) history of eczema, and/or 3) family history of asthma.
The primary objective is to assess the ability to administer 2 doses of dexamethasone to infants hospitalized with bronchiolitis meeting the inclusion criteria. The literature suggests that prompt intervention in the course of bronchiolitis disease is important for possibly altering the immune response and sequelae. Therefore, it is important that we are able to demonstrate the ability to initiate the intervention while the child is still hospitalized and complete the number of doses with the desired anti-inflammatory effect. We aim to successfully administer both doses of the study medication in 87% of infants enrolled.
Enrolling sites will recruit participants in collaboration with outpatient practices within Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care services to children (<24 months old). Sites will serve a population base of at least 40% Medicaid/uninsured children, <60% non-Hispanic White children, or >40% of families residing in rural communities.
Participants will be enrolled on the study for approximately 30 days. While in the study they will receive dexamethasone at a dose of 0.6 mg/kg/dose orally (max 16 mg/dose) per day for 2 days. The 1st dose will be given while the infant is inpatient (within 24 hours following enrollment). The 2nd dose will be given on Day 2, either inpatient or at home. The time interval between doses will be between 12 and 48 hours. Participants will be followed for safety information 30 days (±4 days) after the 2nd dose.
The study duration is 24 months (2 months start-up, 17 months enrollment, 1 month follow-up, and 3 months close-out and data analysis).
- Conditions
- Bronchiolitis
- Being tested
- Dexamethasone Oral
- Keywords
- Infants <24 months of age hospitalized with bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
Dexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose)
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Administration | Experimental | Dexamethasone will be given orally to all consented participants. Two doses will be administered within 12-48 hours, with at least the 1st dose administered during the bronchiolitis hospitalization. If the participant is discharged before the 2nd dose, it will be administered at home. Receives: Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that receive 2 doses of dexamethasone per protocol.
A total of N=30 recruited participants will be enrolled into the study. In the primary objective, we expect 26 out of 30 (87%) participating infants will successfully receive 2 doses of dexamethasone per protocol.
Measured: Intervention: 72 hours; Follow-up: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start9 Oct 2023 (estimated)
- Primary completion9 Mar 2025 (estimated)
- Study completion14 Apr 2025 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open-label single-arm pilot study to assess feasibility of study procedures.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institutes of Health (NIH), University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Kari Neemann, MD, Study chair, University of NebraskaAshley Deschamp, MD,MS, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994183
- Sponsor's protocol ID
- 275605
- Acronym
- BroncHI
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bronchiolitis in Hospitalized Infants (BroncHI) Study: A Feasibility Trial Aimed to Identify and Treat Hospitalized Infants With Bronchiolitis Most at Risk for Recurrent Wheezing and Asthma
- ClinicalTrials.gov ID
- NCT05994183
- Acronym / sponsor ID
- BroncHI / 275605
- Conditions
- Bronchiolitis
- Keywords
- Infants <24 months of age hospitalized with bronchiolitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- National Institutes of Health (NIH), University of Nebraska
- Study start
- 9 Oct 2023 (estimated)
- Primary completion
- 9 Mar 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 that meet at least one of the following criteria: 1) history of breathing problems, 2) history of eczema, and/or 3) family history of asthma.
The primary objective is to assess the ability to administer 2 doses of dexamethasone to infants hospitalized with bronchiolitis meeting the inclusion criteria. The literature suggests that prompt intervention in the course of bronchiolitis disease is important for possibly altering the immune response and sequelae. Therefore, it is important that we are able to demonstrate the ability to initiate the intervention while the child is still hospitalized and complete the number of doses with the desired anti-inflammatory effect. We aim to successfully administer both doses of the study medication in 87% of infants enrolled.
Enrolling sites will recruit participants in collaboration with outpatient practices within Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care services to children (<24 months old). Sites will serve a population base of at least 40% Medicaid/uninsured children, <60% non-Hispanic White children, or >40% of families residing in rural communities.
Participants will be enrolled on the study for approximately 30 days. While in the study they will receive dexamethasone at a dose of 0.6 mg/kg/dose orally (max 16 mg/dose) per day for 2 days. The 1st dose will be given while the infant is inpatient (within 24 hours following enrollment). The 2nd dose will be given on Day 2, either inpatient or at home. The time interval between doses will be between 12 and 48 hours. Participants will be followed for safety information 30 days (±4 days) after the 2nd dose.
The study duration is 24 months (2 months start-up, 17 months enrollment, 1 month follow-up, and 3 months close-out and data analysis).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label single-arm pilot study to assess feasibility of study procedures.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Administration | Experimental | Drug: Dexamethasone OralDexamethasone will be given orally to all consented participants. Two doses will be administered within 12-48 hours, with at least the 1st dose administered during the bronchiolitis hospitalization. If the participant is discharged before the 2nd dose, it will be administered at home. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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:
- Parental ability to speak and read English or Spanish
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Dexamethasone OralDexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose) | Drug | Dexamethasone Administration |
Primary outcome
Number of participants that receive 2 doses of dexamethasone per protocol.
Time frame: Intervention: 72 hours; Follow-up: 30 days
A total of N=30 recruited participants will be enrolled into the study. In the primary objective, we expect 26 out of 30 (87%) participating infants will successfully receive 2 doses of dexamethasone per protocol.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Yes. The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies.
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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.
Kari Neemann, MD study chair
University of Nebraska
Ashley Deschamp, MD,MS study chair
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone Oral in people with Bronchiolitis, run by IDeA States Pediatric Clinical Trials Network at 2 sites 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants that receive 2 doses of dexamethasone per protocol. (time frame: Intervention: 72 hours; Follow-up: 30 days). 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 14 Sep 2023.