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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02208323
Other study ID # 1406M51386
Secondary ID 12985
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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