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The Bronchiolitis in Hospitalized Infants Study

NCT05994183 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-09-14

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone Oral

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Nebraska

    collaborator OTHER

  • IDeA States Pediatric Clinical Trials Network

    lead NETWORK

Principal Investigators

  • Kari Neemann, MD · University of Nebraska

  • Ashley Deschamp, MD,MS · University of Nebraska

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2025-03-09
Completion
2025-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994183 on ClinicalTrials.gov