HypoxiaPhase 2NCT02208323
Advancement of Modified Bubble CPAP
A Phase 2 study testing Bubble CPAP in people with Hypoxia and Respiratory Distress, run by University of Minnesota at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Hypoxia, Respiratory Distress
- What is being tested?
- Bubble CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUganda
- Study dates
- Jul 2015to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3
Who cannot join
- 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
Show all 10Show fewer
- Recent abdominal surgery or significant abdominal distension
- Agonal respirations
- GCS <3
- Imminent death within the next 1-2hou
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
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.
Read the 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)
- Conditions
- Hypoxia, Respiratory Distress
- Being tested
- Bubble CPAP
- Keywords
- Hypoxia, Respiratory Distress
- Medical subject headings
- Hypoxia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAPDevice
Respiratory assistance
| Study group | Role | What they receive |
|---|---|---|
| Bubble CPAP | Experimental | Bubble CPAP for 28 days Receives: Device: Bubble CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Bjorklund, MD, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208323
- Sponsor's protocol ID
- 1406M51386
- Other IDs
- 12985
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
- ClinicalTrials.gov ID
- NCT02208323
- Acronym / sponsor ID
- 1406M51386
- Conditions
- Hypoxia, Respiratory Distress
- Keywords
- Hypoxia, Respiratory Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bubble CPAP | Experimental | Device: Bubble CPAPBubble CPAP for 28 days |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3
Key exclusion criteria (10 listed)
- Pneumothorax
- Congenital lung disease
- Cyanotic heart disease
- Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
- Nasal tissue injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble CPAPRespiratory assistance | Device | Bubble CPAP |
Primary outcome
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
Time frame: 28 days
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
1 secondary outcome
show decreased mortality in patients treated with a modified bCPAP respiratory support device.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Bjorklund, MD study director
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bubble CPAP in people with Hypoxia and Respiratory Distress, run by University of Minnesota at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.