Advancement of Modified Bubble CPAP

NCT ID: NCT02208323

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Hypoxia Respiratory Distress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bubble CPAP

Bubble CPAP for 28 days

Group Type EXPERIMENTAL

Bubble CPAP

Intervention Type DEVICE

Respiratory assistance

Interventions

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Bubble CPAP

Respiratory assistance

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Bjorklund, MD

Role: STUDY_DIRECTOR

University of Minnesota

Locations

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Gulu Regional Referral Hospital

Gulu, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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12985

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1406M51386

Identifier Type: -

Identifier Source: org_study_id

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