Back to resultsAdvancement of Modified Bubble CPAP
Primary Purpose
Hypoxia, Respiratory Distress
Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
Bubble CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring Hypoxia, Respiratory Distress
Eligibility Criteria
Inclusion Criteria:
- Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3
Exclusion Criteria:
- Pneumothorax
- Congenital lung disease
- Cyanotic heart disease
- Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
- Nasal tissue injury
- Active nosebleed
- Recent abdominal surgery or significant abdominal distension
- Agonal respirations
- GCS <3
- Imminent death within the next 1-2hou
Sites / Locations
- Gulu Regional Referral Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bubble CPAP
Arm Description
Bubble CPAP for 28 days
Outcomes
Primary Outcome Measures
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale
Secondary Outcome Measures
show decreased mortality in patients treated with a modified bCPAP respiratory support device.
Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course
Full Information
NCT ID
NCT02208323
First Posted
August 1, 2014
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02208323
Brief Title
Advancement of Modified Bubble CPAP
Official Title
Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.
Detailed Description
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Respiratory Distress
Keywords
Hypoxia, Respiratory Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bubble CPAP
Arm Type
Experimental
Arm Description
Bubble CPAP for 28 days
Intervention Type
Device
Intervention Name(s)
Bubble CPAP
Intervention Description
Respiratory assistance
Primary Outcome Measure Information:
Title
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
Description
A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale
Time Frame
28 days
Secondary Outcome Measure Information:
Title
show decreased mortality in patients treated with a modified bCPAP respiratory support device.
Description
Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3
Exclusion Criteria:
Pneumothorax
Congenital lung disease
Cyanotic heart disease
Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
Nasal tissue injury
Active nosebleed
Recent abdominal surgery or significant abdominal distension
Agonal respirations
GCS <3
Imminent death within the next 1-2hou
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Bjorklund, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
Facility Information:
Facility Name
Gulu Regional Referral Hospital
City
Gulu
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Advancement of Modified Bubble CPAP
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