Advancement of Modified Bubble CPAP

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208323
• Other study ID #: 1406M51386
• Secondary ID: 12985
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypoxia
• Respiratory Distress

Intervention

Device:
• Bubble CPAP
Respiratory assistance

Locations

Country	Name	City	State
Uganda	Gulu Regional Referral Hospital	Gulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

Uganda, 

Outcome

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