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Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa

NCT03944551 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-06-09

No results posted yet for this study

Summary

This study is being conducted in Mali, Africa.

Pneumonia is a respiratory infection of the lungs caused by bacteria or virus. Some children can develop signs of severe pneumonia and as a result, have difficulty breathing and low levels of oxygen in the blood. In some cases this can progress to death. Patients with signs of severe pneumonia require admission to the hospital for treatment and the treatment includes delivery of oxygen. Currently, in the hospital, oxygen is available for delivery by nasal cannula to children. In this case, oxygen is given through a small plastic tube which delivers oxygen through the nose. However, the amount of oxygen that can be given is limited because of the size of the tube and the amount of oxygen that can go through. However, a new device known as the bubble CPAP machine delivers oxygen through the nose in a way that helps the airways to stay open. This is known to provide better support to children less than 1 year of age who have difficulty breathing with signs of severe pneumonia. The purpose of this study is to evaluate the effectiveness of bubble CPAP in Children up to 5 years of age with with signs of severe pneumonia.

Conditions

Interventions

DEVICE

Bubble CPAP

Those assigned to the bCPAP group will receive a Total flow oxygen at a rate of 2 liters per kilogram to a maximum of 10 liters per minute using the appropriate nasal prongs for the age and size of the patient. The positive end-expiratory pressure (PEEP) provide by bCPAP will start at 8cm HO2. The FIO2 will be adjusted to obtain a saturation of oxygen of 90% or greater.

OTHER

Standard Therapy

For patients in the standard therapy group, oxygen will be delivery by nasal cannula at a flow rate of 4 Liters per minute. If a patient in the standard group after 1 hour of treatment still has a SpO2 \< 90% or meeting criteria of treatment failure the patient will be move from the standard therapy group to the bCPAP group.

Sponsors & Collaborators

  • Center for Vaccine Development - Mali

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Adnan T Bhutta, MBBS · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944551 on ClinicalTrials.gov