Acute Bronchiolitis
Conditions
Keywords
hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone
Brief summary
This is a prospective, randomized, controlled, double-blinded, clinical trial Subject : 3mo \ 24mo. aged infants with bronchiolitis The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Detailed description
Randomly assigned to one of three groups * Group I : nebulized epinephrine + 0.9% saline + placebo * Group II : nebulized epinephrine + 3% saline + placebo * Group III : nebulized epinephrine + 0.9% saline + dexamethasone Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone. The primary outcome is hospital admission within 7 days after the day of enrollment
Interventions
DRUG3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline
DRUG0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* 3mo \ 24mo aged patients with bronchiolitis visit to emergency departments * RDAI score 4-15
Exclusion criteria
* \< 3mo, \> 24mo * infants who had received oral or inhaled corticosteroids during the preceding 2 weeks * infants with a previous episode of wheezing or a diagnosis of asthma * any chronic cardiopulmonary disease * immunodeficiency * infants needed intubation * infants with a previous history of apnea or intubation * infants with side effect of dexamethasone * infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospital admission within 7 days after the day of enrollment | within 7 days | hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RDAI score | baseline, between nebulizer, 60min, 120min, 180min, 240min | RDAI score |
| respiratory rate | baseline, between nebulizer, 60min, 120min, 180min, 240min | respiratory rate |
| Heart rate | baseline, between nebulizer, 60min, 120min, 180min, 240min | Heart rate |
| Oxygen saturation | baseline, between nebulizer, 60min, 120min, 180min, 240min | Oxygen saturation |
| unplanned revisit and admission rate after revisit | in 7days | unplanned revisit admission rate after revisit |
Countries
South Korea
Outcome results
None listed