Advancement of Modified Bubble CPAP

Phase 2

Completed

• Conditions: Respiratory Distress; Hypoxia
• Interventions: Device: Bubble CPAP

• Registration Number: NCT02208323
• Lead Sponsor: University of Minnesota

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)

Study Timeline

• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2015-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bubble CPAP	Bubble CPAP	Bubble CPAP for 28 days

Primary Outcome Measures

Name	Time	Method
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period	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

Secondary Outcome Measures

Name	Time	Method
show decreased mortality in patients treated with a modified bCPAP respiratory support device.	28 days	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

Trial Locations

Locations (1)

Gulu Regional Referral Hospital; 🇺🇬 Gulu, Uganda