Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa
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|ClinicalTrials.gov Identifier: NCT03944551|
Recruitment Status : Terminated (Participant mortality rates were higher than expected.)
First Posted : May 9, 2019
Last Update Posted : June 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Device: Bubble CPAP Other: Standard Therapy||Not Applicable|
This study includes two cohorts. One cohort will participate in an interventional clinical trial and the other cohort will participate in an observational study.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an unblinded, age-stratified, randomized trial with a 2:1 allocation ratio.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||September 26, 2019|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||September 30, 2019|
|Experimental: Bubble CPAP||
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.
- Treatment failure rate [ Time Frame: 2 hours ]
We define treatment failure as the occurrence of any two or more of the following clinical criteria 2 hour after initiation of an intervention:
- Severe hypoxemia (Saturation of oxygen SpO2 <85%) after being on one of the study groups treatments for 2 hours
Increased in respiratory rate by any amount or if respiratory rate remains unchanged after initiation of treatment as follow:
- ≥ 40 breath/min in a child aged 12-23 months
- ≥ 30 breaths/min in a child aged 2-5 years
- Signs of persistent severe respiratory distress defined as head nodding, severe chest indrawing, stridor, apnea, nasal flaring and or grunting.
- Dies while in the hospital.
- Mortality rate [ Time Frame: Through hospital discharge, an average of 1 week ]The difference in mortality between the standard therapy group vs bCPAP group at the time of discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944551
|Center for Vaccine Development - Mali|
|Principal Investigator:||Adnan T Bhutta, MBBS||University of Maryland, Baltimore|