Trial Outcomes & Findings for Croup Dosing Study (NCT NCT06272383)
NCT ID: NCT06272383
Last Updated: 2025-09-08
Results Overview
Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Seven days following initial presentation to the ED with croup.
Results posted on
2025-09-08
Participant Flow
Participant milestones
| Measure |
0.15mg/kg Dexamethasone
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Standard Practice of 0.6mg/kg Dexamethasone
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
0.15mg/kg Dexamethasone
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Standard Practice of 0.6mg/kg Dexamethasone
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
|---|---|---|
|
Overall Study
The investigational drugs were going to expire and to use the pilot data for the definitive trial
|
6
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0.15mg/kg Dexamethasone
n=19 Participants
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Standard Practice of 0.6mg/kg Dexamethasone
n=21 Participants
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=19 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=19 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=19 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=19 Participants
|
9 Participants
n=21 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=19 Participants
|
12 Participants
n=21 Participants
|
24 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
weight (Kg)
|
13.17 Kg
n=19 Participants
|
13.69 Kg
n=21 Participants
|
13.45 Kg
n=40 Participants
|
|
croup severity
Mild croup
|
16 participants
n=19 Participants
|
16 participants
n=21 Participants
|
32 participants
n=40 Participants
|
|
croup severity
Moderate croup
|
3 participants
n=19 Participants
|
4 participants
n=21 Participants
|
7 participants
n=40 Participants
|
|
croup severity
Severe croup
|
0 participants
n=19 Participants
|
1 participants
n=21 Participants
|
1 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Seven days following initial presentation to the ED with croup.Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
Outcome measures
| Measure |
0.15mg/kg Dexamethasone
n=19 Participants
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Standard Practice of 0.6mg/kg Dexamethasone
n=21 Participants
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
|---|---|---|
|
Return Visits or Readmissions to the Hospital
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: within 7 and 30 days of treatment.Adverse events following treatment with either of the 2 doses of dexamethasone. AEs: Disseminated varicella, gastrointestinal bleeding, unspecified bleeding, pneumonia, sepsis, febrile convulsion, bacteria tracheitis, tachycardia/fast heartbeat, and restlessness.
Outcome measures
| Measure |
0.15mg/kg Dexamethasone
n=19 Participants
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
Standard Practice of 0.6mg/kg Dexamethasone
n=21 Participants
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg
|
|---|---|---|
|
Adverse Events
|
0 participants
|
0 participants
|
Adverse Events
0.15mg/kg Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Practice of 0.6mg/kg 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place