Croup
Conditions
Keywords
Primary Care, Treatment, Croup, Corticosteroids, Prednisone, Dexamethasone, Randomized trial
Brief summary
This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.
Interventions
DRUGPrednisone
2 mgs/kg for 3 days
DRUGDexamethasone
0.6 mgs for one day, then placebo for 2 days
Sponsors
Washington University Pediatric and Adolescent Ambulatory Research Consortium
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup.
Exclusion criteria
* Severe croup or impending respiratory failure; * another reason to indicate the need for hospitalization; * symptoms or signs to suggest another cause of stridor; * active varicella infection; * diabetes; * known immunodeficiency disease; * chronic respiratory disease such as CF (Cystic Fibrosis); * prescribed a controller medication or oral steroids for asthma in the past 12 months; * a history of TB(tuberculosis) in a household member; * treatment for seizures; * treatment with epinephrine or oral corticosteroids for this croup episode before enrollment; * not accompanied by their legal guardian; * the accompanying adult will not be in the same household as the child for the next four days; * parent/legal guardian is unavailable for telephone follow-up or does not speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Additional Health Care | 11 days | The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Croup Symptoms | 12 days | — |
| Nights With Disturbed Sleep | 12 days | — |
| Parental Stress | 12 days | Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0. |
| Time Missed From Work | 12 days | — |
| Number of Participants With Reported Side Effects | 12 days | — |
Countries
United States
Participant flow
Recruitment details
Children were recruited from 10 primary care pediatric practices over two winters: between October 26, 2009 and April 16, 2010; and between September 6, 2010 and April 29, 2011.
Pre-assignment details
103 children were assessed for eligibility. 16 were excluded prior to randomization. reasons were: did not meet inclusion criteria (10), declined to participte (6).
Participants by arm
| Arm | Count |
|---|---|
| Prednisone | 41 |
| Dexamethasone | 46 |
| Total | 87 |
Baseline characteristics
| Characteristic | Dexamethasone | Prednisone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 41 Participants | 87 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.11 years STANDARD_DEVIATION 1.58 | 2.67 years STANDARD_DEVIATION 1.43 | 2.9 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 46 participants | 41 participants | 87 participants |
| Sex: Female, Male Female | 18 Participants | 13 Participants | 31 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 46 |
| serious Total, serious adverse events | 0 / 41 | 0 / 46 |
Outcome results
Primary
Additional Health Care
The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.
Time frame: 11 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prednisone | Additional Health Care | 7 percentage of participants |
| Dexamethasone | Additional Health Care | 2 percentage of participants |
p-value: 0.34Fisher Exact
Secondary
Duration of Croup Symptoms
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisone | Duration of Croup Symptoms | 2.2 days | Standard Deviation 1.3 |
| Dexamethasone | Duration of Croup Symptoms | 2.8 days | Standard Deviation 2.7 |
p-value: 0.63Wilcoxon (Mann-Whitney)
Secondary
Nights With Disturbed Sleep
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisone | Nights With Disturbed Sleep | 1.21 nights | Standard Deviation 2.69 |
| Dexamethasone | Nights With Disturbed Sleep | 0.68 nights | Standard Deviation 1.55 |
Secondary
Number of Participants With Reported Side Effects
Time frame: 12 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prednisone | Number of Participants With Reported Side Effects | 26 percentage of participants |
| Dexamethasone | Number of Participants With Reported Side Effects | 24 percentage of participants |
p-value: 1Fisher Exact
Secondary
Parental Stress
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisone | Parental Stress | 1.56 days | Standard Deviation 2.69 |
| Dexamethasone | Parental Stress | 1.39 days | Standard Deviation 1.08 |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
Time Missed From Work
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisone | Time Missed From Work | 3.79 Hours | Standard Deviation 7.4 |
| Dexamethasone | Time Missed From Work | 4.06 Hours | Standard Deviation 5.54 |
p-value: 0.24Wilcoxon (Mann-Whitney)