Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114478
Status:
UNKNOWN
Last Update Posted:
2008-01-25
First Post:
2005-06-15
Brief Title:
Trial of Epinephrine and Albuterol in Bronchiolitis
Sponsor:
Kern Medical Center
Organization:
Kern Medical Center
Study Overview
Official Title:
Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better A childs 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
Nebulizer 1 Treatment
Treatment 30 minutes approximately Nebulizer 2
Treatment 60 minutes approximately Nebulizer 3
Treatment 120 minutes approximately
The baby will be reevaluated and either discharged home or revert to standard therapy If the baby is discharged directly from the emergency department ED we will call you in three days time to see how heshe is doing
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
Nebulizer 1 Treatment
Treatment 30 minutes approximately Nebulizer 2
Treatment 60 minutes approximately Nebulizer 3
Treatment 120 minutes approximately
The baby will be reevaluated and either discharged home or revert to standard therapy If the baby is discharged directly from the emergency department ED we will call you in three days time to see how heshe is doing
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None