Advancement of Modified Bubble CPAP

Study Overview
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Brief Summary
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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
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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)

Official Title
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Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety

Conditions
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Hypoxia, Respiratory Distress

Intervention / Treatment
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* Device: Bubble CPAP


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bubble CPAP<br>Bubble CPAP for 28 days | Device: Bubble CPAP<br>* Respiratory assistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, Respiratory Distress