The Bronchiolitis in Hospitalized Infants Study

NCT05994183 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 275605
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiolitis

Keywords

Infants <24 months of age hospitalized with bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Intervention: 72 hours; Follow-up: 30 days

Study Arms (1)

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.

Drug: Dexamethasone Oral

Interventions

Dexamethasone Oral DRUG

Dexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose)

Dexamethasone Administration

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IDeA States Pediatric Clinical Trials Network: lead
• National Institutes of Health (NIH): collaborator
• University of Nebraska: collaborator

Study Sites (2)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kari Neemann, MD

  University of Nebraska

  STUDY CHAIR

• Ashley Deschamp, MD,MS

  University of Nebraska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: An open-label single-arm pilot study to assess feasibility of study procedures.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: October 9, 2023
• Primary Completion: March 9, 2025
• Study Completion: April 14, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: NIH Public Access Policy ensures public access to the published results of NIH-funded research. Scientists are required to submit final peer-reviewed journal manuscripts from NIH funds to the digital archive PubMed Central upon publication acceptance. ECHO ISPCTN Publications and Presentations Policy, ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering Committee has approved and ratified the Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from NIH and the DCOC NIH Data Sharing Policy, the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Trial results will be submitted to ClinicalTrials.gov. Additional plans are to publish results in peer reviewed journals. Researchers may request trial data by contacting Jeannette Lee, PhD, at the DCOC.
• Access Criteria: TBA

Locations

US (2)