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there was no eligible patients
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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.
Randomly assigned to one of three groups
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.9% saline + oral placebo | Placebo Comparator | nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline |
|
| 3% saline + oral placebo | Experimental | nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline |
|
| 0.9% saline + oral dexamethasone | Active Comparator | nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% saline + oral placebo | Drug | nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| hospital admission within 7 days after the day of enrollment | hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department) | within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| RDAI score | RDAI score | baseline, between nebulizer, 60min, 120min, 180min, 240min |
| respiratory rate | respiratory rate | baseline, between nebulizer, 60min, 120min, 180min, 240min |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9% saline + oral dexamethasone | Drug | nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline |
|
| Heart rate | Heart rate | baseline, between nebulizer, 60min, 120min, 180min, 240min |
| Oxygen saturation | Oxygen saturation | baseline, between nebulizer, 60min, 120min, 180min, 240min |
| unplanned revisit and admission rate after revisit | unplanned revisit admission rate after revisit | in 7days |
| D017670 |
| Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |