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The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).
Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.
The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.
Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | |||
| albuterol (salbutamol) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Successful hospital discharge at three days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in severity of disease score | ||
| Improvement in respiratory status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Walsh, Paul Walsh, MD MSc(peds) | Kern Medical Center, David Geffen School of Medicine, UCLA | Principal Investigator |
| Paul Walsh | Research Director, Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kern Medical Center | Bakersfield | California | 93312 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15359199 | Background | Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. Eur J Emerg Med. 2004 Oct;11(5):265-72. doi: 10.1097/00063110-200410000-00005. | |
| 18370982 | Derived | Walsh P, Caldwell J, McQuillan KK, Friese S, Robbins D, Rothenberg SJ. Comparison of nebulized epinephrine to albuterol in bronchiolitis. Acad Emerg Med. 2008 Apr;15(4):305-13. doi: 10.1111/j.1553-2712.2008.00064.x. |
| Label | URL |
|---|---|
| Research assistant site for this study. Restricted access. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 31, 2012 | |
| Reset | Nov 28, 2012 | |
| Release | Mar 19, 2014 | |
| Reset | Apr 22, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2012 | Nov 28, 2012 | |||
| Mar 19, 2014 |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Apr 22, 2014 |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |