Advancement of Modified Bubble CPAP

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Respiratory Distress
• Intervention / Treatment: Device: Bubble CPAP

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• Uganda
  • Gulu, Uganda
    • Gulu Regional Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bubble CPAP; Bubble CPAP for 28 days	Device: Bubble CPAP; Respiratory assistance

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Study Director: Ashley Bjorklund, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hypoxia; Respiratory Distress
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 1406M51386; 12985 (Other Grant/Funding Number: Thrasher Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO