Ignite Creation Date:
2024-05-06 @ 1:09 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03944551
Status:
TERMINATED
Last Update Posted:
2020-06-09
First Post:
2019-04-22
Brief Title:
Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali Africa
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Participant mortality rates were higher than expected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 childs 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 ClinicalTrialsgov registration will refer only to the Intervention Cohort
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 childs 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 ClinicalTrialsgov registration will refer only to the Intervention Cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None