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

NCT ID: NCT03944551

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2019-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bubble CPAP

Group Type: EXPERIMENTAL

Bubble CPAP

Intervention Type: 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.

Standard Therapy

Group Type: OTHER

Standard Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Severe malnutrition
• Informed written consent obtained

Patients with the following conditions who meet eligible criteria can benefit from bCPAP:

• Bronchiolitis
• Respiratory viral infection
• Lung collapse / atelectasis
• Asthma exacerbation
• Patients with congenital heart disease with heart failure
• Malaria
• Severe Anemia
• Sepsis
• Meningitis
• Any patient with increased respiratory effort who meet the eligible criteria

We will include patients with progression to severe pneumonia during the hospitalization and those ones with chronic diseases too.

Definitions:

• Head nodding: a movement of the head synchronous with inspiration indicating severe respiratory distress
• Chest indrawing: lower chest wall goes in when the child breathes in
• Lethargy: is defined as "an infant who does not wake up on stimulation or, on waking, subsequently moves only on stimulation or does not move at all"
• Not able to drink: refers to "difficulty feeding or not feeding well (in an infant who was previously feeding well)"
• Convulsions: During the enrollment process, the danger sign for 'convulsions' will be collected by asking about the number and duration of seizures.
• Severe malnutrition Severe acute malnutrition is defined as per WHO as the presence of edema of both feet or severe wasting (weight-for-height/length <-3SD) or mid upper arm circumference < 115 mm [19]
• Chronic disease: Children with chronic lung or respiratory disease may be admitted to the study. We will not exclude patients from the study on the basis of a long history of symptoms.

Exclusion Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Vaccine Development - Mali

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Adnan Bhutta

Division Head, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adnan T Bhutta, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Center for Vaccine Development - Mali

Bamako, , Mali

Countries

Mali

Other Identifiers

HP-82800

Identifier Type: -

Identifier Source: org_study_id