NCT03944551

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

Use of Bubble Continuous Positive Airway Pressure (bCPAP) With High Flow Settings in Treatment of Respiratory Distress Secondary to Signs of Severe Pneumonia in Pediatric Patients in Mali

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 12 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes two cohorts. One cohort will participate in an interventional clinical trial and the other cohort will participate in an observational study. Interventional Cohort: The first cohort will include 600 children with signs of severe pneumonia, 1 year up to 5 years of age. Signs of severe pneumonia include fast breathing, difficulty breathing and who are very sick (not able to drink, vomiting, having seizures, are very sleepy or with severe malnutrition). Two out of every three children will receive oxygen with the bubble CPAP and one out of every three children will receive treatment with oxygen with regular nasal cannula. The treatment assignment will be determined randomly. We will follow up participants during their entire hospitalization. During this time we will collect information on the child's illness, test results and treatment. Observational Cohort: The second cohort will include 450 children with signs of severe pneumonia, under 1 year of age. In Mali, bubble CPAP is currently given as standard of care (when possible) for children with signs of severe pneumonia, under 1 year of age; therefore, children in this cohort will already be receiving bubble CPAP as standard of care prior to enrollment. The only research activities will be to follow the children during their hospitalization and collect information about their clinical condition, test results, treatment and the amount of oxygen required during the hospital admission. The remainder of the information in this ClinicalTrials.gov registration will refer only to the Intervention Cohort.

Conditions

• Pneumonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-26
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2019-05-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Mali