Hypoxia Clinical Trial
Official title:
Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 5 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Gulu Regional Referral Hospital | Gulu |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28 days | |
Secondary | 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 | 28 days |
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