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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: Lung Diseases and Conditions – Bronchitis
2023 AUG 25 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05994183 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •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. |
| Current Secondary Outcome Measures | Not Provided |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT05994183 |
Descriptive Information
| Brief Title | The Bronchiolitis in Hospitalized Infants 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 |
| Brief 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. |
| 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 |
| Study Type | Interventional |
| Study Phase | Early Phase 1 |
| Study Design | Allocation: N/A |
| Intervention Model: Single Group Assignment | |
| Primary Purpose: Other | |
| Masking: None (Open Label) | |
| Intervention Model Description: An open-label single-arm pilot study to assess feasibility of study procedures. | |
| Condition | Bronchiolitis |
| Intervention | •Drug: Dexamethasone Oral |
| Dexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose) | |
| Study Arms | •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 dischar | |
| Interventions: | |
| ⚬Drug: Dexamethasone Oral |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 30 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | 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 |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 0 months to 24 months |
| Yes | |
| Contacts | Primary contact: |
| Backup contact: |
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| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05994183 |
| Other Study ID Numbers | 275605 |
| Has Data Monitoring Committee | Yes |
| Studies a |
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| Studies a |
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| Plan to Share Data | Yes |
| Plan to Share Data (IPD) Description | 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 |
| IDeA States Pediatric Clinical Trials Network | |
| Collaborators | ⚬National Institutes of Health (NIH) |
| ⚬University of |
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| Investigators | Study Chair: |
| Study Chair: |
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| Information Provided By | IDeA States Pediatric Clinical Trials Network |
| Verification Date |
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