NCT02208323

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

August 1, 2014

Last Update Submit

October 30, 2019

Conditions

HypoxiaRespiratory Distress

Keywords

HypoxiaRespiratory Distress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • show decreased mortality in patients treated with a modified bCPAP respiratory support device.

    28 days

Study Arms (1)

Bubble CPAP

EXPERIMENTAL

Bubble CPAP for 28 days

Device: Bubble CPAP

Interventions

Bubble CPAPDEVICE

Respiratory assistance

Bubble CPAP

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation \<92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score \>3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulu Regional Referral Hospital

Gulu, Uganda

Location

MeSH Terms

Conditions

HypoxiaDyspnea

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Ashley Bjorklund, MD

    University of Minnesota

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 5, 2014

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)