Trial Outcomes & Findings for Steroid Use in Non-RSV Bronchiolitis (NCT NCT04221087)

NCT ID: NCT04221087

Last Updated: 2023-03-21

Results Overview

Measurement of hospital length of stay in hours

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: Admission vitals through discharge paperwork printing time, average of 24-96 hours
• Results posted on: 2023-03-21

Participant Flow

Participant milestones

Measure	Placebo Arm 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.) Placebos: Sugar water based on same ml dosing of intervention arm drug	Dexamethasone Arm 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.) Dexamethasone Oral: 0.6mg/kg/dose - single oral dose administration to intervention arm
Overall Study STARTED	2	1
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo Arm n=2 Participants 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.) Placebos: Sugar water based on same ml dosing of intervention arm drug	Dexamethasone Arm n=1 Participants 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.) Dexamethasone Oral: 0.6mg/kg/dose - single oral dose administration to intervention arm	Total n=3 Participants Total of all reporting groups
Age, Continuous	2.75 months STANDARD_DEVIATION 1.77 • n=2 Participants	12 months STANDARD_DEVIATION NA • n=1 Participants	5.83 months STANDARD_DEVIATION 5.48 • n=3 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	1 Participants n=1 Participants	2 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Admission vitals through discharge paperwork printing time, average of 24-96 hours

Population: No data was collected

Measurement of hospital length of stay in hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: No data was collected

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Will compare respiratory assessment via MTS 12 hours after admission and at discharge, average of 24-96 hours from admission

Population: No data was collected

Measurement of reducing severity of bronchiolitis by assessment with modified TAL score (MTS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Admission to time of discharge to home or transfer to ICU or acute care floor, usual time frame is 24-72 hours

Population: No data was collected

Measurement of reducing severity of bronchiolitis by evaluation of patient outcome - discharge, transfer to ICU or acute care floor

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Discharge to 7 days

Population: No data was collected

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

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Allison Williams

University of PIttsburgh

Phone: 4126925135

Email: williamsae2@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place