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Advancement of Modified Bubble CPAP

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 2

Conditions

Hypoxia
Respiratory Distress

Treatments

Device: Bubble CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT02208323
12985 (Other Grant/Funding Number)
1406M51386

Details and patient eligibility

About

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.

Full 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)

Enrollment

87 patients

Sex

All

Ages

1 month to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

87 participants in 1 patient group

Bubble CPAP
Experimental group
Description:
Bubble CPAP for 28 days
Treatment:
Device: Bubble CPAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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