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

NCT03944551 | Terminated

• 1 other identifier: HP-82800
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Treatment failure rate

  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.

  2 hours

Secondary Outcomes (1)

• Mortality rate

  Through hospital discharge, an average of 1 week

Study Arms (2)

Bubble CPAP

EXPERIMENTAL

Device: Bubble CPAP

Standard Therapy

OTHER

Other: Standard Therapy

Interventions

Bubble CPAP DEVICE

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.

Bubble CPAP

Standard Therapy OTHER

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.

Standard Therapy

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalization
• Age 12 months up to 5 years
• Fast breathing defined as: (Using a timing device to count rate for one full minute)
• ≥ 40 breath/min in a child aged 12-23 months
• ≥ 30 breaths/min in a child aged 2-5 years
• Any of the following respiratory signs: wheezing, nasal flaring, chest indrawing, cyanosis, grunting, head nodding, stridor and/or oxygen saturation \<90%.
• Informed written consent obtained Or
• Age 12 months up to 5 years
• Weight up to 20Kg
• With cough AND/OR any sign of difficult breathing Plus ONE general danger sign as follow:
• Not able to drink
• Persistent vomiting
• Convulsions
• Lethargy or unconscious
• Stridor in a calm child or

You may not qualify if:

• Skin breakdown around the nose and mouth
• Facial trauma
• Persistent episodes of vomiting: more than 3 episodes in 1 hour.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Center for Vaccine Development - Mali: collaborator

Study Sites (1)

Center for Vaccine Development - Mali

Bamako, Mali

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Adnan T Bhutta, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Department of Pediatrics

Model Details: This is an unblinded, age-stratified, randomized trial with a 2:1 allocation ratio.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 9, 2019
• Study Start: September 26, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

MA (1)