A Phase 2 interventional study of Bubble CPAP in Hypoxia and Respiratory Distress, sponsored by University of Minnesota. Completed at 1 site in Uganda. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
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.
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)
1,232 studies on the registry are indexed under Hypoxia; 242 are open to participants now.
This study's enrollment of 87 is above the median of 45 across 854 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bubble CPAP for 28 days
Device: Bubble CPAP
Respiratory assistance
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
Time frame: 28 days
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
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Minnesota