PneumoniaNCT01396759
Use of Bubble Continuous Positive Airway Pressure Compared to Nasal Prong Oxygen or Humidified High Flow in Children Under Five With Severe Pneumonia and Hypoxaemia
A study testing Bubble continuous positive airway pressure, Humidified high flow air / O2 mix at 2 l/kg/min and Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min in people with Pneumonia and Hypoxaemia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1). Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pneumonia, Hypoxaemia
- What is being tested?
- Bubble continuous positive airway pressure, Humidified high flow air / O2 mix at 2 l/kg/min and Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2011to Jun 2015
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex, aged 0-4 years, with severe/very severe pneumonia (per WHO guidelines) and hypoxaemia (SpO2 < 90%) will be included in our study in the ARI Unit of the Longer Stay Ward (LSW), High Dependency Unit HDU, and ICU unit of Dhaka Hospital of ICDDR,B.
Who cannot join
- Children with uncorrected cyanotic CHD, hypercapnoea (PCO2 > 65 mm of Hg), status asthmaticus and upper-airway obstruction, and those for whom inform consent can't be secured from their parents/ care-givers. Children with features (any two of three criteria given below) of "treatment failure" on admission (before enrollment into the study) will also be excluded from the study. Arterial blood gas analysis will be performed to check the exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Bubble CPAP Compared to Nasal Prong Oxygen or Humidified High Flow in Children Under Five With Severe Pneumonia and Hypoxaemia: a Randomized Trial
Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1). Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is most frequently delivered to neonates using conventional mechanical ventilators, and thus there is minimal or no cost saving. There are other ways of delivering CPAP, such as Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries (3).
High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy, and closer monitoring. "High flow" delivers uncertain levels of CPAP, so it is not clearly superior to bubble-CPAP, and there have been no controlled comparative trials of these two techniques.
Read more
Pneumonia and malnutrition are two of the most common co-morbidities in children in developing countries (5). In hospitals in resource-poor settings, children with severe malnutrition and pneumonia often present with respiratory distress with or without severe hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation through nasal prong or face mask. Support from bubble CPAP might help to effectively treat hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its complications, and reduce mortality.
Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed thesis, unpublished data). They often need mechanical ventilation, with attendant costs, complications and high mortality rates. However, no published data are available about the use of bubble-CPAP in children with pneumonia and malnutrition and there have been no controlled trials of CPAP in developing countries.
The Hypothesis is:
In children with severe pneumonia and hypoxaemia the probability of treatment failure (see definition below) will be significantly lower when respiratory support is initially provided by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard oxygen flow.
Read the detailed description
- Design and Methods
1.1 Study design: This will be a randomised, controlled study in which the investigators will prospectively provide intervention in children under the age of 5 years admitted to the Dhaka Hospital of ICDDR,B and fulfilling the inclusion criteria (January 2011 and December 2012), subject to the obtaining written informed consent from respective parents/care-givers.
1.3 Intervention and comparators
Children under five admitted to the SCU of ICDDR, B with pneumonia and hypoxaemia will be studied. This study will evaluate the proportions of deaths in children under five in three treatment arms.
The investigators will use sealed envelopes to randomly assign the children to one of three treatment arms. In first arm, children will receive bubble CPAP; in 2nd arm, children will receive standard O2 supplementation by nasal cannula at 0.5 - 2 l/min; in the 3rd arm, children will receive humidified high flow air/O2 mix at 2 l/kg/min through nasal cannula. The three arms will be compared for rates of treatment failure (see below).
During the study period, children (whether under ventilation or not) in all three study arms will also receive standardized hospital management for pneumonia and malnutrition.
"Treatment failure" will be standardized, based on clinical and monitoring data.
During the study period any child from either study group who develops the features of "treatment failure" (any two of three criteria in the definition below) will be managed according to best practice in the clinical context. "Treatment failure" is the criteria to be followed to decide intubation and mechanical ventilation.
Laboratory investigations:
Routine: Blood for total and differential count of white blood cell (WBC), haematocrit, culture and sensitivity, serum electrolytes and creatinine, stool culture and urine culture, chest radiograph (CXR).
Protocol-specific: Arterial blood gas analysis, tuberculin skin test (TST), gastric lavage for acid fast bacilli (AFB) and culture for MTB.
1.4 Measurements
All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
1.5 Criteria for primary outcome
.
The primary outcome, by intention to treat analysis will be reached if a child:
- Has any two or more of the following three criteria of treatment failure (after at least one hour of intervention)
- Severe hypoxaemia (SpO2<85%) after being on one of the study arm treatments for > 1 hour
- Clinical signs of exhaustion, including active contraction of respiratory muscles with paradoxical abdominal and thoracic motion, gasping, severe chest wall in-drawing
- PCO2 > 80mm Hg and pH < 7.2 on capillary blood gas OR B. Receives intubation and/or mechanical ventilation OR C. Dies while in hospital or within 30 days of discharge OR D. Absconds * while still on the allocated respiratory support.
- If they abscond the day before they are due to be discharged and they are off oxygen and are well, then that's just a mother's choice to go home early, such children should not be put in the category of equivalent of treatment failure. 2 Sample Size Calculation and Outcome (Primary and Secondary) Variable(s) Background, recent data (1st January until 31st October, 2010) from the ICU of the Dhaka Hospital of the ICDDR,B revealed that the approximate treatment failure from the management of hypoxaemia in children with pneumonia and severe malnutrition was 30%. The investigators assumed that the new intervention would result in a reduction of treatment failure from 30% to 18% (i.e. a 40% absolute reduction). Thus to detect a difference of 40% in the death from hypoxaemia with 90% power and type 1 error 0.03 (the investigators are intending to do a mid-term analysis and for that the investigators are considering type 1 error 0.03 instead of 0.05 ), the sample would be 295 children in each group {sample size = [(p1×q1 + p2q2)/ (p2-p1)2]×factor for α, β; where is the p1 is the percentage of the "treatment failure", q1 is the 1- p1, p2 is the percentage of the expected "treatment failure" from intervention; q2 is the 1- p2, α is the type 1 error and β is the type 2 error and factor for α, β with 90% power is 11.9}. Considering 10% drop out after admission in hospital, the total sample size is at least 325 in each group. So, our total sample size will be 325×3=975. The patients will be enrolled over a period of two years.
- Conditions
- Pneumonia, Hypoxaemia
- Being tested
- Bubble continuous positive airway pressure, Humidified high flow air / O2 mix at 2 l/kg/min, Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min
- Keywords
- Bubble CPAP, Humidified high flow, Hypoxaemia, Nasal prong, Severe pneumonia
- 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 continuous positive airway pressureProcedure or surgery
All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
Humidified high flow air / O2 mix at 2 l/kg/minProcedure or surgery
Humidified high flow air / O2 mix at 2 l/kg/min through nasal canula. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
Standard O2 supplementation by nasal cannula at 0.5 - 2 l/minProcedure or surgery
Standard O2 supplementation will be given by nasal cannula at 0.5 - 2 l/min. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
| Study group | Role | What they receive |
|---|---|---|
| bubble CPAP | Experimental | Children will receive bubble CPAP Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece. The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries. Receives: Procedure: Bubble continuous positive airway pressure |
| High flow air/ oxygen mix | Experimental | High flow air/ oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air / oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). Receives: Procedure: Humidified high flow air / O2 mix at 2 l/kg/min |
| Standard O2 supplementation by nasal prongs | Active comparator | Standard O2 supplementation by nasal prongs @ 0.5-2.0 litre per minute Receives: Procedure: Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Severe hypoxaemia (SpO2<85%) after being on one of the study arm treatments for >1 hour Clinical signs of exhaustion, including active contraction of respiratory muscles with paradoxical abdominal and thoracic motion, gasping, severe chest wall in-drawing PCO2 >80mm Hg and pH<7.2 on capillary blood gas OR
Measured: 24 months
Secondary outcomes (1)
Mortality rate
- Mortality rate calculated at hospital discharge
- Rate of need for mechanical ventilation
- Rates of nosocomial infections
- Rates of multi-organ failure at 7 days
- Length of hospital stay
- Rate of absconding
- Bacterial aetiology
- Rates of isolation of TB
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- AusAID, University of Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396759
- Sponsor's protocol ID
- PR-10088
- Status last verified
- Jun 2015
- First submitted
- 6 Jul 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chisti 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 26296950
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bubble CPAP Compared to Nasal Prong Oxygen or Humidified High Flow in Children Under Five With Severe Pneumonia and Hypoxaemia: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01396759
- Acronym / sponsor ID
- PR-10088
- Conditions
- Pneumonia, Hypoxaemia
- Keywords
- Bubble CPAP, Humidified high flow, Hypoxaemia, Nasal prong, Severe pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 975 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- AusAID, University of Melbourne
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jul 2011 (estimated)
- 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.
Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1). Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is most frequently delivered to neonates using conventional mechanical ventilators, and thus there is minimal or no cost saving. There are other ways of delivering CPAP, such as Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries (3).
High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy, and closer monitoring. "High flow" delivers uncertain levels of CPAP, so it is not clearly superior to bubble-CPAP, and there have been no controlled comparative trials of these two techniques.
Pneumonia and malnutrition are two of the most common co-morbidities in children in developing countries (5). In hospitals in resource-poor settings, children with severe malnutrition and pneumonia often present with respiratory distress with or without severe hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation through nasal prong or face mask. Support from bubble CPAP might help to effectively treat hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its complications, and reduce mortality.
Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed thesis, unpublished data). They often need mechanical ventilation, with attendant costs, complications and high mortality rates. However, no published data are available about the use of bubble-CPAP in children with pneumonia and malnutrition and there have been no controlled trials of CPAP in developing countries.
The Hypothesis is:
In children with severe pneumonia and hypoxaemia the probability of treatment failure (see definition below) will be significantly lower when respiratory support is initially provided by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard oxygen flow.
Detailed description
- Design and Methods
1.1 Study design: This will be a randomised, controlled study in which the investigators will prospectively provide intervention in children under the age of 5 years admitted to the Dhaka Hospital of ICDDR,B and fulfilling the inclusion criteria (January 2011 and December 2012), subject to the obtaining written informed consent from respective parents/care-givers.
1.3 Intervention and comparators
Children under five admitted to the SCU of ICDDR, B with pneumonia and hypoxaemia will be studied. This study will evaluate the proportions of deaths in children under five in three treatment arms.
The investigators will use sealed envelopes to randomly assign the children to one of three treatment arms. In first arm, children will receive bubble CPAP; in 2nd arm, children will receive standard O2 supplementation by nasal cannula at 0.5 - 2 l/min; in the 3rd arm, children will receive humidified high flow air/O2 mix at 2 l/kg/min through nasal cannula. The three arms will be compared for rates of treatment failure (see below).
During the study period, children (whether under ventilation or not) in all three study arms will also receive standardized hospital management for pneumonia and malnutrition.
"Treatment failure" will be standardized, based on clinical and monitoring data.
During the study period any child from either study group who develops the features of "treatment failure" (any two of three criteria in the definition below) will be managed according to best practice in the clinical context. "Treatment failure" is the criteria to be followed to decide intubation and mechanical ventilation.
Laboratory investigations:
Routine: Blood for total and differential count of white blood cell (WBC), haematocrit, culture and sensitivity, serum electrolytes and creatinine, stool culture and urine culture, chest radiograph (CXR).
Protocol-specific: Arterial blood gas analysis, tuberculin skin test (TST), gastric lavage for acid fast bacilli (AFB) and culture for MTB.
1.4 Measurements
All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
1.5 Criteria for primary outcome
.
The primary outcome, by intention to treat analysis will be reached if a child:
- Has any two or more of the following three criteria of treatment failure (after at least one hour of intervention)
- Severe hypoxaemia (SpO2<85%) after being on one of the study arm treatments for > 1 hour
- Clinical signs of exhaustion, including active contraction of respiratory muscles with paradoxical abdominal and thoracic motion, gasping, severe chest wall in-drawing
- PCO2 > 80mm Hg and pH < 7.2 on capillary blood gas OR B. Receives intubation and/or mechanical ventilation OR C. Dies while in hospital or within 30 days of discharge OR D. Absconds * while still on the allocated respiratory support.
- If they abscond the day before they are due to be discharged and they are off oxygen and are well, then that's just a mother's choice to go home early, such children should not be put in the category of equivalent of treatment failure. 2 Sample Size Calculation and Outcome (Primary and Secondary) Variable(s) Background, recent data (1st January until 31st October, 2010) from the ICU of the Dhaka Hospital of the ICDDR,B revealed that the approximate treatment failure from the management of hypoxaemia in children with pneumonia and severe malnutrition was 30%. The investigators assumed that the new intervention would result in a reduction of treatment failure from 30% to 18% (i.e. a 40% absolute reduction). Thus to detect a difference of 40% in the death from hypoxaemia with 90% power and type 1 error 0.03 (the investigators are intending to do a mid-term analysis and for that the investigators are considering type 1 error 0.03 instead of 0.05 ), the sample would be 295 children in each group {sample size = [(p1×q1 + p2q2)/ (p2-p1)2]×factor for α, β; where is the p1 is the percentage of the "treatment failure", q1 is the 1- p1, p2 is the percentage of the expected "treatment failure" from intervention; q2 is the 1- p2, α is the type 1 error and β is the type 2 error and factor for α, β with 90% power is 11.9}. Considering 10% drop out after admission in hospital, the total sample size is at least 325 in each group. So, our total sample size will be 325×3=975. The patients will be enrolled over a period of two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bubble CPAP | Experimental | Procedure: Bubble continuous positive airway pressureChildren will receive bubble CPAP Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece. The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries. |
| High flow air/ oxygen mix | Experimental | Procedure: Humidified high flow air / O2 mix at 2 l/kg/minHigh flow air/ oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air / oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). |
| Standard O2 supplementation by nasal prongs | Active comparator | Procedure: Standard O2 supplementation by nasal cannula at 0.5 - 2 l/minStandard O2 supplementation by nasal prongs @ 0.5-2.0 litre per minute |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of either sex, aged 0-4 years, with severe/very severe pneumonia (per WHO guidelines) and hypoxaemia (SpO2 < 90%) will be included in our study in the ARI Unit of the Longer Stay Ward (LSW), High Dependency Unit HDU, and ICU unit of Dhaka Hospital of ICDDR,B.
Key exclusion criteria (1 listed)
- Children with uncorrected cyanotic CHD, hypercapnoea (PCO2 > 65 mm of Hg), status asthmaticus and upper-airway obstruction, and those for whom inform consent can't be secured from their parents/ care-givers. Children with features (any two of three criteria given below) of "treatment failure" on admission (before enrollment into the study) will also be excluded from the study. Arterial blood gas analysis will be performed to check the exclusion criteria
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 continuous positive airway pressureAll children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis. | Procedure or surgery | bubble CPAP |
| Humidified high flow air / O2 mix at 2 l/kg/minHumidified high flow air / O2 mix at 2 l/kg/min through nasal canula. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis. | Procedure or surgery | High flow air/ oxygen mix |
| Standard O2 supplementation by nasal cannula at 0.5 - 2 l/minStandard O2 supplementation will be given by nasal cannula at 0.5 - 2 l/min. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis. | Procedure or surgery | Standard O2 supplementation by nasal prongs |
Primary outcome
Treatment failure
Time frame: 24 months
Severe hypoxaemia (SpO2<85%) after being on one of the study arm treatments for >1 hour Clinical signs of exhaustion, including active contraction of respiratory muscles with paradoxical abdominal and thoracic motion, gasping, severe chest wall in-drawing PCO2 >80mm Hg and pH<7.2 on capillary blood gas OR
1 secondary outcome
Mortality rate
Time frame: 24 months
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 28 Jul 2015.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 continuous positive airway pressure, Humidified high flow air / O2 mix at 2 l/kg/min and Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min in people with Pneumonia and Hypoxaemia, 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 1 inclusion and 1 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 28 Jul 2015. 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?
Treatment failure (time frame: 24 months). 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 NCT01396759, which also lists 1 linked publication.
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 28 Jul 2015.