PneumoniaNCT03944551
Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa
A study testing Bubble CPAP and Standard Therapy in people with Pneumonia, run by University of Maryland, Baltimore at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 5 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Bubble CPAP and Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteMali
- Study dates
- 26 Sep 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cases must meet the all following inclusion criteria for eligibility to be placed on bCPAP
- 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
Show all 39Show fewer
- 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]
- Progression to case definition during hospitalization: Cases that progress to severe pneumonia or meet the inclusion criteria previously mentioned during hospitalization but do not meet the definition during the time of admission because the disease is in the early stages of illness will be included.
- 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.
Who cannot join
- Cases that meet any of the following exclusion criteria will be ineligible to enroll:
- Skin breakdown around the nose and mouth
- Facial trauma
- Persistent episodes of vomiting: more than 3 episodes in 1 hour.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Bubble CPAP, Standard Therapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAPDevice
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bubble CPAP | Experimental | Not described Receives: Device: Bubble CPAP |
| Standard Therapy | Other | Not described Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
Mortality rate
The difference in mortality between the standard therapy group vs bCPAP group at the time of discharge.
Measured: Through hospital discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start26 Sep 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Why it stopped: Participant mortality rates were higher than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an unblinded, age-stratified, randomized trial with a 2:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Vaccine Development - Mali
- Responsible party
- Principal investigator, Adnan Bhutta, University of Maryland, Baltimore
- Investigators
- Adnan T Bhutta, MBBS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944551
- Sponsor's protocol ID
- HP-82800
- Status last verified
- Jun 2020
- First submitted
- 22 Apr 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03944551
- Acronym / sponsor ID
- HP-82800
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant mortality rates were higher than expected.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Center for Vaccine Development - Mali
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an unblinded, age-stratified, randomized trial with a 2:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Bubble CPAP | Experimental | Device: Bubble CPAP |
| Standard Therapy | Other | Other: Standard Therapy |
Who may qualify
- Ages
- 12 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (39 listed)
- Cases must meet the all following inclusion criteria for eligibility to be placed on bCPAP
- Hospitalization
- Age 12 months up to 5 years
- Fast breathing defined as: (Using a timing device to count rate for one full minute)
- Any of the following respiratory signs: wheezing, nasal flaring, chest indrawing, cyanosis, grunting, head nodding, stridor and/or oxygen saturation <90%.
Key exclusion criteria (4 listed)
- Skin breakdown around the nose and mouth
- Facial trauma
- Persistent episodes of vomiting: more than 3 episodes in 1 hour.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble CPAPThose 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. | Device | Bubble CPAP |
| Standard TherapyFor 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. | Other | Standard Therapy |
Primary outcome
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.
1 secondary outcome
Mortality rate
Time frame: Through hospital discharge, an average of 1 week
Results and safety
The study was stopped early (reason given: Participant mortality rates were higher than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan T Bhutta, MBBS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble CPAP and Standard Therapy in people with Pneumonia, run by University of Maryland, Baltimore at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participant mortality rates were higher than expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.