Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848115
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-04-13
Brief Title:
BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Understanding the Role of Bilevel Positive Airway Pressure BiPAP in Pediatric Acute Asthma Exacerbations A Prospective Randomized Double Blind Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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 goal of this clinical trial is to study if starting bi-level positive airway pressure BiPAP a mask that gives pressure to the lungs works well for children in the emergency department with moderate to severe asthma attacks The main questions it aims to answer are
1 Whether initiation of BiPAP at the same time as continuous beta-agonist therapy eg nebulized albuterol will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy
2 Whether early BiPAP changes how the lungs function in children with asthma attacks
3 Whether children receiving early BiPAP experience more issues or side effects than those children who do not
All children will receive the usual treatment for asthma attacks if they are still experiencing moderate to severe symptoms after the initial treatment they will be asked to participate in the study Participants will then wear a mask while they are receiving the continuous beta-agonist therapy Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team
Researchers will compare BiPAP versus Control Sham BiPAP groups to see if there is a difference in how long continuous beta-agonist therapy is needed how the lungs are functioning and number or type of side effects
1 Whether initiation of BiPAP at the same time as continuous beta-agonist therapy eg nebulized albuterol will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy
2 Whether early BiPAP changes how the lungs function in children with asthma attacks
3 Whether children receiving early BiPAP experience more issues or side effects than those children who do not
All children will receive the usual treatment for asthma attacks if they are still experiencing moderate to severe symptoms after the initial treatment they will be asked to participate in the study Participants will then wear a mask while they are receiving the continuous beta-agonist therapy Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team
Researchers will compare BiPAP versus Control Sham BiPAP groups to see if there is a difference in how long continuous beta-agonist therapy is needed how the lungs are functioning and number or type of side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61HL158814-01A1 | NIH | None | httpsreporternihgovquickSearch1R61HL158814-01A1 |