Severe PneumoniaNCT03870243
Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia
A study testing Bubble CPAP and Low flow oxygen in people with Severe Pneumonia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Principal Investigator: Mohammod Jobayer Chisti Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial Proposed… Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Severe Pneumonia
- What is being tested?
- Bubble CPAP and Low flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 1 siteBangladesh
- Study dates
- 2 Sep 2019to 27 Jul 2022
- 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 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 month and 59 months,
- Meet WHO clinical criteria for severe pneumonia with hypoxemia.
- Oxygen saturation <90% despite standard flow oxygen therapy
- Parent/guardian gives informed consent to participate in the study
Who cannot join
- Known congenital heart disease, asthma, or upper -airway obstruction
- Tracheostomy
- Pneumothorax
- Needs mechanical ventilation for any specific reason as decided by the clinician
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Mohakhali, 1212
About this study
Official title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
Principal Investigator: Mohammod Jobayer Chisti
Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
Read more
Proposed start date: 1st July 2018, Estimated end date: 31st December 2022
Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objectives:
Stages I and II
- To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II
- To record adverse events following use of bubble CPAP in these settings
- To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system
Stage III:
- To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia
- To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure \& mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia
- To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.
Read the detailed description
Methodology:
Cluster randomized controlled clinical trial
Methodology:
- Stages I and II: Feasibility/demonstration stage will be done as an internal pilot in 3 hospitals
- Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP
- Stage III: Implementation of bubble CPAP will be done in 12 hospitals a. It will be done following a cluster randomized design
Data collection-socio-demographic and clinical data will be collected using structured questionnaire by trained nurses and physicians.
Research Site:
St. Paulos Millennium Medical College, Yekatit 12 and Tikur Anbessa Specialized hospitals, 14 district hospitals
Number of Participants/Patients:
Stage I-30 children in each tertiary hospital (this stage has completed and we enrolled 49 children from two tertiary hospitals; these 49 enrolled children took double of our anticipated time {4 months}) Stage II- 20 children in each general hospital (2 general/district hospitals, we have enrolled total 40 children from this two hospitals from January 2020 to July 2020, which included COVID-19 period) Stage III-1240 children in 12 general/district hospitals (620 in bubble CPAP arm and 620 in WHO standard low flow arm; each hospital will be the cluster and 6 will be randomized to each arm)
Main Inclusion Criteria:
- Age between 1 month and 59 months
- Meet WHO clinical criteria for severe pneumonia with hypoxemia
- Hypoxemia (Oxygen saturation <90% in room air)
- Parent/guardian gives informed consent to participate in the study
Statistical Analysis:
- STATA -14: for initial two phases descriptive analysis of level of feasibility and acceptability will be performed
- For the phase III: We shall follow the principle of intention to treat. --Treatment failure and/or death will be analyzed using χ² or Fisher's exact tests as appropriate.
- Primary and secondary outcomes will be compared by calculating relative risks (RRs) and their 95% confidence intervals.
- Log-linear binomial regression will be applied to adjust for covariates to evaluate the true impact of bubble CPAP in evaluating primary and secondary outcomes and to adjust for baseline differences.
- Continuous variables will be analyzed using the Student t-test or the Mann-Whitney test as appropriate.
Study Duration:
48 months.
- Conditions
- Severe Pneumonia
- Being tested
- Bubble CPAP, Low flow oxygen
- Keywords
- Bubble CPAP, Young Children, Severe Pneumonia, Hypoxemia, Treatment failure, Mortality
- Medical subject headings
- Pneumonia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAPDevice
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
Low flow oxygenDevice
To see the effectiveness of low flow oxygen in children with severe pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Bubble CPAP | Active comparator | 6 hospitals will be selected randomly for this arm Receives: Device: Bubble CPAP |
| Low flow oxygen | Active comparator | 6 hospitals will be selected for low flow oxygen therapy Receives: Device: Low flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
Patient level and health professional level challenge is the outcome of phase I and II. All will be measured in number and reported in percentage. For stage I and II: Primary outcome: operational challenges that may include availability of pulse oxymetry, IV cannula, IV antibiotics, oxygen supply system and nasal catheters for treating severe pneumonia Secondary outcomes: prevalence of severe pneumonia associated hypoxemia, their treatment practices, adverse events, mortality and treatment failure
Measured: 7 months
For stage III: Primary outcome: Treatment failure
According to this protocol treatment failure will be declared if the following criteria are met:
- Presence of severe hypoxemia (SpO2<85%) at any time after at least one hour of intervention plus severe respiratory distress when the child is receiving BCPAP/LF OR, B. If the patient developed the indication of mechanical ventilation when the child is receiving BCPAP/LF OR, C. If the patient died during hospitalization OR, D. If the patient left against medical advice (LAMA) due to lack of improvement or deterioration of the child during hospitalization
All will be measured in number and reported in percentage.
Measured: 12-18 months (Mid April 2021 to Mid October 2022)
Secondary outcomes (1)
Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered
All will be measured in number and reported in percentage.
Measured: 12-18 months (Mid April 2021 to Mid October 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start2 Sep 2019
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- 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
- Children aged 1-59 months with Severe Pneumonia in Ethiopia, divided in two arms; one arm will get bCPAP other arm will get WHO recommended low flow oxygen.
- Masking
- None (open label)
- Enrolment
- 1,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Mohammod Jobayer Chisti, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870243
- Sponsor's protocol ID
- PR-18052
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2019
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the final outcome after completing the study
Publications
UNICEF. Committing to Child Survival: A Promise Renewed. Progress Report 2015 2015
Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
PubMed 25280870You D, Hug L, Ejdemyr S, Idele P, Hogan D, Mathers C, Gerland P, New JR, Alkema L; United Nations Inter-agency Group for Child Mortality Estimation (UN IGME). Global, regional, and national levels and trends in under-5 mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet. 2015 Dec 5;386(10010):2275-86. doi: 10.1016/S0140-6736(15)00120-8. Epub 2015 Sep 8.
PubMed 26361942Graham SM, English M, Hazir T, Enarson P, Duke T. Challenges to improving case management of childhood pneumonia at health facilities in resource-limited settings. Bull World Health Organ. 2008 May;86(5):349-55. doi: 10.2471/blt.07.048512.
PubMed 18545737Rahman AE, Moinuddin M, Molla M, Worku A, Hurt L, Kirkwood B, Mohan SB, Mazumder S, Bhutta Z, Raza F, Mrema S, Masanja H, Kadobera D, Waiswa P, Bahl R, Zangenberg M, Muhe L; Persistent Diarrhoea Research Group. Childhood diarrhoeal deaths in seven low- and middle-income countries. Bull World Health Organ. 2014 Sep 1;92(9):664-71. doi: 10.2471/BLT.13.134809. Epub 2014 Jun 23.
PubMed 25378757Duke T, Tamburlini G, Silimperi D; Paediatric Quality Care Group. Improving the quality of paediatric care in peripheral hospitals in developing countries. Arch Dis Child. 2003 Jul;88(7):563-5. doi: 10.1136/adc.88.7.563. No abstract available.
PubMed 12818896Duke T, Peel D, Graham S, Howie S, Enarson PM, Jacobson R. Oxygen concentrators: a practical guide for clinicians and technicians in developing countries. Ann Trop Paediatr. 2010;30(2):87-101. doi: 10.1179/146532810X12637745452356.
PubMed 20522295McKiernan C, Chua LC, Visintainer PF, Allen H. High flow nasal cannulae therapy in infants with bronchiolitis. J Pediatr. 2010 Apr;156(4):634-8. doi: 10.1016/j.jpeds.2009.10.039. Epub 2009 Dec 29.
PubMed 20036376Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3.
PubMed 21369809Duke T. CPAP: a guide for clinicians in developing countries. Paediatr Int Child Health. 2014 Feb;34(1):3-11. doi: 10.1179/2046905513Y.0000000102. Epub 2013 Dec 6.
PubMed 24165032Chisti MJ, Salam MA, Smith JH, Ahmed T, Pietroni MA, Shahunja KM, Shahid AS, Faruque AS, Ashraf H, Bardhan PK, Sharifuzzaman, Graham SM, Duke T. Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1057-65. doi: 10.1016/S0140-6736(15)60249-5. Epub 2015 Aug 19.
PubMed 26296950Koti J, Murki S, Gaddam P, Reddy A, Reddy MD. Bubble CPAP for respiratory distress syndrome in preterm infants. Indian Pediatr. 2010 Feb;47(2):139-43. doi: 10.1007/s13312-010-0021-6. Epub 2009 May 20.
PubMed 19578226Chisti MJ, Duke T, Ahmed T, Shahunja KM, Shahid ASMSB, G. FAS, et al. The Use of Bubble CPAP and Humidified High Flow Nasal Cannula Oxygen Therapy in Children with Severe Pneumonia and Hypoxemia: A Systematic Review of the Evidence. Bangladesh Crit Care J. 2014; 2:71-8
Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8. doi: 10.1038/sj.jp.7211325.
PubMed 15858606Courtney SE, Kahn DJ, Singh R, Habib RH. Bubble and ventilator-derived nasal continuous positive airway pressure in premature infants: work of breathing and gas exchange. J Perinatol. 2011 Jan;31(1):44-50. doi: 10.1038/jp.2010.55. Epub 2010 Apr 15.
PubMed 20393478
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03870243
- Acronym / sponsor ID
- PR-18052
- Conditions
- Severe Pneumonia
- Keywords
- Bubble CPAP, Young Children, Severe Pneumonia, Hypoxemia, Treatment failure, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,240 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 12 Mar 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.
Principal Investigator: Mohammod Jobayer Chisti
Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
Proposed start date: 1st July 2018, Estimated end date: 31st December 2022
Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objectives:
Stages I and II
- To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II
- To record adverse events following use of bubble CPAP in these settings
- To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system
Stage III:
- To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia
- To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure \& mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia
- To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.
Detailed description
Methodology:
Cluster randomized controlled clinical trial
Methodology:
- Stages I and II: Feasibility/demonstration stage will be done as an internal pilot in 3 hospitals
- Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP
- Stage III: Implementation of bubble CPAP will be done in 12 hospitals a. It will be done following a cluster randomized design
Data collection-socio-demographic and clinical data will be collected using structured questionnaire by trained nurses and physicians.
Research Site:
St. Paulos Millennium Medical College, Yekatit 12 and Tikur Anbessa Specialized hospitals, 14 district hospitals
Number of Participants/Patients:
Stage I-30 children in each tertiary hospital (this stage has completed and we enrolled 49 children from two tertiary hospitals; these 49 enrolled children took double of our anticipated time {4 months}) Stage II- 20 children in each general hospital (2 general/district hospitals, we have enrolled total 40 children from this two hospitals from January 2020 to July 2020, which included COVID-19 period) Stage III-1240 children in 12 general/district hospitals (620 in bubble CPAP arm and 620 in WHO standard low flow arm; each hospital will be the cluster and 6 will be randomized to each arm)
Main Inclusion Criteria:
- Age between 1 month and 59 months
- Meet WHO clinical criteria for severe pneumonia with hypoxemia
- Hypoxemia (Oxygen saturation <90% in room air)
- Parent/guardian gives informed consent to participate in the study
Statistical Analysis:
- STATA -14: for initial two phases descriptive analysis of level of feasibility and acceptability will be performed
- For the phase III: We shall follow the principle of intention to treat. --Treatment failure and/or death will be analyzed using χ² or Fisher's exact tests as appropriate.
- Primary and secondary outcomes will be compared by calculating relative risks (RRs) and their 95% confidence intervals.
- Log-linear binomial regression will be applied to adjust for covariates to evaluate the true impact of bubble CPAP in evaluating primary and secondary outcomes and to adjust for baseline differences.
- Continuous variables will be analyzed using the Student t-test or the Mann-Whitney test as appropriate.
Study Duration:
48 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Children aged 1-59 months with Severe Pneumonia in Ethiopia, divided in two arms; one arm will get bCPAP other arm will get WHO recommended low flow oxygen.
| Arm | Type | Receives |
|---|---|---|
| Bubble CPAP | Active comparator | Device: Bubble CPAP6 hospitals will be selected randomly for this arm |
| Low flow oxygen | Active comparator | Device: Low flow oxygen6 hospitals will be selected for low flow oxygen therapy |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 1 month and 59 months,
- Meet WHO clinical criteria for severe pneumonia with hypoxemia.
- Oxygen saturation <90% despite standard flow oxygen therapy
- Parent/guardian gives informed consent to participate in the study
Key exclusion criteria (4 listed)
- Known congenital heart disease, asthma, or upper -airway obstruction
- Tracheostomy
- Pneumothorax
- Needs mechanical ventilation for any specific reason as decided by the clinician
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 CPAPTo see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia | Device | Bubble CPAP |
| Low flow oxygenTo see the effectiveness of low flow oxygen in children with severe pneumonia | Device | Low flow oxygen |
Primary outcome
For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
Time frame: 7 months
Patient level and health professional level challenge is the outcome of phase I and II. All will be measured in number and reported in percentage. For stage I and II: Primary outcome: operational challenges that may include availability of pulse oxymetry, IV cannula, IV antibiotics, oxygen supply system and nasal catheters for treating severe pneumonia Secondary outcomes: prevalence of severe pneumonia associated hypoxemia, their treatment practices, adverse events, mortality and treatment failure
For stage III: Primary outcome: Treatment failure
Time frame: 12-18 months (Mid April 2021 to Mid October 2022)
According to this protocol treatment failure will be declared if the following criteria are met: A. Presence of severe hypoxemia (SpO2<85%) at any time after at least one hour of intervention plus severe respiratory distress when the child is receiving BCPAP/LF OR, B. If the patient developed the indication of mechanical ventilation when the child is receiving BCPAP/LF OR, C. If the patient died during hospitalization OR, D. If the patient left against medical advice (LAMA) due to lack of improvement or deterioration of the child during hospitalization All will be measured in number and reported in percentage.
1 secondary outcome
Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered
Time frame: 12-18 months (Mid April 2021 to Mid October 2022)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- BackgroundUNICEF. Committing to Child Survival: A Promise Renewed. Progress Report 2015 2015
- Background: PubMed 25280870Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
- Background: PubMed 26361942You D, Hug L, Ejdemyr S, Idele P, Hogan D, Mathers C, Gerland P, New JR, Alkema L; United Nations Inter-agency Group for Child Mortality Estimation (UN IGME). Global, regional, and national levels and trends in under-5 mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet. 2015 Dec 5;386(10010):2275-86. doi: 10.1016/S0140-6736(15)00120-8. Epub 2015 Sep 8.
- Background: PubMed 18545737Graham SM, English M, Hazir T, Enarson P, Duke T. Challenges to improving case management of childhood pneumonia at health facilities in resource-limited settings. Bull World Health Organ. 2008 May;86(5):349-55. doi: 10.2471/blt.07.048512.
- Background: PubMed 25378757Rahman AE, Moinuddin M, Molla M, Worku A, Hurt L, Kirkwood B, Mohan SB, Mazumder S, Bhutta Z, Raza F, Mrema S, Masanja H, Kadobera D, Waiswa P, Bahl R, Zangenberg M, Muhe L; Persistent Diarrhoea Research Group. Childhood diarrhoeal deaths in seven low- and middle-income countries. Bull World Health Organ. 2014 Sep 1;92(9):664-71. doi: 10.2471/BLT.13.134809. Epub 2014 Jun 23.
- Background: PubMed 12818896Duke T, Tamburlini G, Silimperi D; Paediatric Quality Care Group. Improving the quality of paediatric care in peripheral hospitals in developing countries. Arch Dis Child. 2003 Jul;88(7):563-5. doi: 10.1136/adc.88.7.563. No abstract available.
- Background: PubMed 20522295Duke T, Peel D, Graham S, Howie S, Enarson PM, Jacobson R. Oxygen concentrators: a practical guide for clinicians and technicians in developing countries. Ann Trop Paediatr. 2010;30(2):87-101. doi: 10.1179/146532810X12637745452356.
- Background: PubMed 20036376McKiernan C, Chua LC, Visintainer PF, Allen H. High flow nasal cannulae therapy in infants with bronchiolitis. J Pediatr. 2010 Apr;156(4):634-8. doi: 10.1016/j.jpeds.2009.10.039. Epub 2009 Dec 29.
- Background: PubMed 21369809Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3.
- Background: PubMed 24165032Duke T. CPAP: a guide for clinicians in developing countries. Paediatr Int Child Health. 2014 Feb;34(1):3-11. doi: 10.1179/2046905513Y.0000000102. Epub 2013 Dec 6.
- Background: PubMed 26296950Chisti MJ, Salam MA, Smith JH, Ahmed T, Pietroni MA, Shahunja KM, Shahid AS, Faruque AS, Ashraf H, Bardhan PK, Sharifuzzaman, Graham SM, Duke T. Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1057-65. doi: 10.1016/S0140-6736(15)60249-5. Epub 2015 Aug 19.
- Background: PubMed 19578226Koti J, Murki S, Gaddam P, Reddy A, Reddy MD. Bubble CPAP for respiratory distress syndrome in preterm infants. Indian Pediatr. 2010 Feb;47(2):139-43. doi: 10.1007/s13312-010-0021-6. Epub 2009 May 20.
- Individual participant dataSharing planned: No. We will share the final outcome after completing the study
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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.
Mohammod Jobayer Chisti, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
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 Low flow oxygen in people with Severe Pneumonia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 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: finished, as of the sponsor's last update on 7 Aug 2023. 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 Bangladesh. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03870243, which also lists 25 linked publications.
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 7 Aug 2023.