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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02208323 |
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Date of registration:
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01/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Advancement of Modified Bubble CPAP
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Scientific title:
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Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02208323 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Ashley Bjorklund, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Month
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoxia
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Respiratory Distress
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Intervention(s)
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Device: Bubble CPAP
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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show decreased mortality in patients treated with a modified bCPAP respiratory support device.
[Time Frame: 28 days]
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Secondary ID(s)
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12985
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1406M51386
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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