PneumoniaNoGoLo2NCT06176664
Oxygen Therapy for Children With Moderate Hypoxemia in Malawi
A study testing Low flow oxygen and High-flow nasal cannula oxygen in people with Pneumonia, run by Johns Hopkins University at 1 site in Malawi.
Trial summary
The goal of this pilot clinical trial is to compare standard of care, low-flow oxygen, and high-flow nasal canula oxygen in pediatric patients aged 1-59 months with pneumonia and an oxygen saturation of 90-93% in Malawi. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Low flow oxygen and High-flow nasal cannula oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteMalawi
- Study dates
- 15 May 2024to 30 Nov 2024
- 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
- 1-59 months of age
- Pneumonia (as defined by the World Health Organization)
- Oxygen saturation 90-93% without oxygen
Who cannot join
- Emergency signs (signs of severe illness as defined by the World Health Organization) including:
- absent or obstructed breathing,
- severe respiratory distress,
- shock,
- decreased mental status,
- convulsions, or
- severe dehydration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Therapy for Children With Moderate Hypoxemia in Malawi: Pilot Randomized Control Trial
The goal of this pilot clinical trial is to compare standard of care, low-flow oxygen, and high-flow nasal canula oxygen in pediatric patients aged 1-59 months with pneumonia and an oxygen saturation of 90-93% in Malawi. The main question it aims to answer is:
- Does the protocol for the randomized control trial work well?
- Can the researchers safely conduct the protocol for the trial?
Participants will be randomly assigned to one of the three groups (normal care without oxygen, low-flow oxygen, and high-flow nasal cannula oxygen) and treated with that therapy in the hospital. Researchers will look at the ability to safely conduct each part of the study.
Read the detailed description
Pneumonia is the leading infectious cause of under 5-year-old deaths globally and responsible for \>50% of deaths in Africa. The World Health Organization (WHO) defines low blood oxygen saturation (SpO2) levels (hypoxemia) as 90%. Hypoxemia is identified in 31% of child pneumonia cases in Africa and is a key marker of elevated mortality risk. When children are hypoxemic, the WHO recommends oxygen treatment. Importantly, the WHO threshold of 90% for hypoxemia was based on concerns over limited oxygen supply and hospital over-crowding in low- and middle-income countries (LMICs), rather than quality evidence. In most LMICs, low oxygen flow is the mainstay of oxygen delivery. Recently, in high-income settings high-flow nasal cannula (HFNC) oxygen has emerged as a safe and effective alternative. HFNC oxygen delivers higher flow warmed, humidified gas via nasal prongs to reverse hypoxemia, and potentially improve outcomes.
Recent evidence challenges whether the WHO \& 90% hypoxemia threshold is optimal for identifying all children at higher risk of mortality in LMICs. One meta-analysis from 13 LMICs reported 3.66-fold-higher odds of death (95% confidence interval (CI), 1.42, 9.47) for children with a SpO2 93%. The investigators research from Malawi and Bangladesh established children with pneumonia and SpO2 between 90-93% (moderate hypoxemia) is common, and, compared to higher SpO2 levels, conveys higher mortality risk. To date, African children with a SpO2 90-93% are not recommended for oxygen treatment. Observational data from Malawi found children with moderate hypoxemia and treated with oxygen had higher survival than those referred with a SpO2 90%. Currently, no randomized trials have determined whether low flow oxygen or HFNC oxygen treatment reduces the mortality of children with moderate hypoxemia (SpO2 90-93%) in African LMICs.
Aim 1: Conduct a pilot open label, three armed, parallel, randomized controlled trial (RCT) comparing standard care, low-flow oxygen, and HFNC oxygen for children with clinical pneumonia and a SpO2 90-93% to determine feasibility of a larger trial. The investigators hypothesize it will be feasible to recruit, randomize, treat, and safely follow-up all participants. Children with SpO2 90-93% will be randomized 1:1:1 to standard care without oxygen (controls), low flow oxygen (intervention #1), or HFNC oxygen (intervention #2). The primary outcome will be feasibility, defined as the proportion of enrolled children with 2 protocol violations. Secondary outcomes include consent refusal, intervention efficacy, participant attrition, and safety.
Aim 2: Determine the prevalence of young Malawian children with a SpO2 90-93% at the designated study hospital. The investigators hypothesize a SpO2 90-93% will be common among children presenting to the trial hospital. The investigators will measure the SpO2 of all children under-five years old (not limited to pneumonia cases) presenting to the hospital 1 week per month over 12-months. Conservatively assuming an average volume of 30 children per day, based on prior data, the investigators will generate 1,400 SpO2 measurements.
- Conditions
- Pneumonia
- Being tested
- Low flow oxygen, High-flow nasal cannula oxygen
- Keywords
- Pneumonia, High flow nasal cannula oxygen, Oxygen, Low and Middle Income Countries, pediatrics
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow oxygenDevice
Standard nasal cannula oxygen up to 2 liters/minute
High-flow nasal cannula oxygenDevice
High-flow nasal cannula with heating and humidification up to 2 liters/kilogram/minute
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will receive pneumonia care per World Health Organization guidelines. If their oxygen saturation falls below 90% after enrollment, they will be treated with low-flow oxygen. |
| Low-flow Oxygen | Experimental | Participants will be treated with low-flow oxygen to achieve a goal oxygen saturation above 94% Receives: Device: Low flow oxygen |
| High-flow Nasal Cannula Oxygen | Experimental | Participants will be treated with high-flow nasal cannula oxygen to achieve a goal oxygen saturation above 94%. Receives: Device: High-flow nasal cannula oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study protocol as assessed by protocol violations
Determine overall protocol fidelity, defined as the percentage of enrolled children with < 2 protocol violations, of an open-label, three arm randomized controlled trial comparing low-flow and high-flow nasal cannula (HFNC) oxygen to standard of care without oxygen therapy
Measured: Enrollment up to 14 days
Secondary outcomes (6)
Caregiver Trial Acceptability
Determine caregiver trial acceptability, defined as the percentage of caregivers of eligible children who consent to study participation.
Measured: Day of screening and enrollment
Feasibility of screening and enrollment as assessed by percentage of inclusion and exclusion violations
Determine the feasibility of screening and enrollment, defined as the percentage of enrolled children with no inclusion or exclusion criteria violations.
Measured: Day of screening and enrollment
Feasibility of randomization as assessed by percentage of children receiving intervention
Determine feasibility of randomization, defined as percentage of children actively receiving the assigned intervention within 1 hours of randomization
Measured: 1 hour after randomization
Fidelity to treatment failure study definition as assessed by percentage of children with correct treatment failure classification
Determine fidelity to treatment failure study definition, defined as the percentage of children with a correct treatment failure classification
Measured: Enrollment up to 14 days
Fidelity to respiratory supportive care protocol as assessed by percentage of children without a respiratory support protocol violation
Determine fidelity to respiratory supportive care protocol, defined as the proportion of children without a respiratory support protocol violation
Measured: Enrollment up to 14 days
Feasibility of at home follow up as assessed by percentage of participants followed up at home
Determine feasibility of at home follow up defined as percentage of patients successfully followed up at home with assessment of vital status
Measured: Enrollment up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 May 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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 PneumoniaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot trial to assess feasibility of the protocol for a three-armed, open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Eric E McCollom, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176664
- Sponsor's protocol ID
- IRB00421624
- Acronym
- NoGoLo2
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research proposed is a pilot randomized, open-label trial of acute lower respiratory infection with moderate hypoxemia oxygen use in Malawi. The pilot trial will enroll 21 participants with a primary outcome of study feasibility. The datasets will report de-identified patient outcomes including mortality, hospital length of stay, and treatment failure as well as trial feasibility and acceptability data. The shared format of data will be .csv files.
Publications
Tortosa F, Izcovich A, Carrasco G, Varone G, Haluska P, Sanguine V. High-flow oxygen nasal cannula for treating acute bronchiolitis in infants: A systematic review and meta-analysis. Medwave. 2021 May 12;21(4):e8190. doi: 10.5867/medwave.2021.04.8190. English, Spanish.
PubMed 34086669Luo J, Duke T, Chisti MJ, Kepreotes E, Kalinowski V, Li J. Efficacy of High-Flow Nasal Cannula vs Standard Oxygen Therapy or Nasal Continuous Positive Airway Pressure in Children with Respiratory Distress: A Meta-Analysis. J Pediatr. 2019 Dec;215:199-208.e8. doi: 10.1016/j.jpeds.2019.07.059. Epub 2019 Sep 27.
PubMed 31570155Lin J, Zhang Y, Xiong L, Liu S, Gong C, Dai J. High-flow nasal cannula therapy for children with bronchiolitis: a systematic review and meta-analysis. Arch Dis Child. 2019 Jun;104(6):564-576. doi: 10.1136/archdischild-2018-315846. Epub 2019 Jan 17.
PubMed 30655267Kawaguchi A, Yasui Y, deCaen A, Garros D. The Clinical Impact of Heated Humidified High-Flow Nasal Cannula on Pediatric Respiratory Distress. Pediatr Crit Care Med. 2017 Feb;18(2):112-119. doi: 10.1097/PCC.0000000000000985.
PubMed 27741041McKiernan 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 20036376Moreel L, Proesmans M. High flow nasal cannula as respiratory support in treating infant bronchiolitis: a systematic review. Eur J Pediatr. 2020 May;179(5):711-718. doi: 10.1007/s00431-020-03637-0. Epub 2020 Mar 31.
PubMed 32232547Hutchings FA, Hilliard TN, Davis PJ. Heated humidified high-flow nasal cannula therapy in children. Arch Dis Child. 2015 Jun;100(6):571-5. doi: 10.1136/archdischild-2014-306590. Epub 2014 Dec 1.
PubMed 25452315McCollum ED, Mvalo T, Eckerle M, Smith AG, Kondowe D, Makonokaya D, Vaidya D, Billioux V, Chalira A, Lufesi N, Mofolo I, Hosseinipour M. Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial. Lancet Respir Med. 2019 Nov;7(11):964-974. doi: 10.1016/S2213-2600(19)30243-7. Epub 2019 Sep 24.
PubMed 31562059Chaparro CM, Suchdev PS. Anemia epidemiology, pathophysiology, and etiology in low- and middle-income countries. Ann N Y Acad Sci. 2019 Aug;1450(1):15-31. doi: 10.1111/nyas.14092. Epub 2019 Apr 22.
PubMed 31008520Allardet-Servent J, Sicard G, Metz V, Chiche L. Benefits and risks of oxygen therapy during acute medical illness: Just a matter of dose! Rev Med Interne. 2019 Oct;40(10):670-676. doi: 10.1016/j.revmed.2019.04.003. Epub 2019 May 1.
PubMed 31054779McCollum ED, Ahmed S, Roy AD, Chowdhury NH, Schuh HB, Rizvi SJR, Hanif AAM, Khan AM, Mahmud A, Pervaiz F, Harrison M, Reller ME, Simmons N, Quaiyum A, Begum N, Santosham M, Checkley W, Moulton LH, Baqui AH; Projahnmo Study Group in Bangladesh. Effectiveness of the 10-valent pneumococcal conjugate vaccine against radiographic pneumonia among children in rural Bangladesh: A case-control study. Vaccine. 2020 Sep 29;38(42):6508-6516. doi: 10.1016/j.vaccine.2020.08.035. Epub 2020 Aug 29.
PubMed 32873404Colbourn T, King C, Beard J, Phiri T, Mdala M, Zadutsa B, Makwenda C, Costello A, Lufesi N, Mwansambo C, Nambiar B, Hooli S, French N, Bar Zeev N, Qazi SA, Bin Nisar Y, McCollum ED. Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: A data linkage study. PLoS Med. 2020 Oct 23;17(10):e1003300. doi: 10.1371/journal.pmed.1003300. eCollection 2020 Oct.
PubMed 33095763Rahman AE, Hossain AT, Nair H, Chisti MJ, Dockrell D, Arifeen SE, Campbell H. Prevalence of hypoxaemia in children with pneumonia in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2022 Mar;10(3):e348-e359. doi: 10.1016/S2214-109X(21)00586-6.
PubMed 35180418McCollum ED, Ginsburg AS. Outpatient Management of Children With World Health Organization Chest Indrawing Pneumonia: Implementation Risks and Proposed Solutions. Clin Infect Dis. 2017 Oct 16;65(9):1560-1564. doi: 10.1093/cid/cix543.
PubMed 29020216Hooli S, Colbourn T, Lufesi N, Costello A, Nambiar B, Thammasitboon S, Makwenda C, Mwansambo C, McCollum ED, King C. Predicting Hospitalised Paediatric Pneumonia Mortality Risk: An External Validation of RISC and mRISC, and Local Tool Development (RISC-Malawi) from Malawi. PLoS One. 2016 Dec 28;11(12):e0168126. doi: 10.1371/journal.pone.0168126. eCollection 2016.
PubMed 28030608
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Therapy for Children With Moderate Hypoxemia in Malawi: Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06176664
- Acronym / sponsor ID
- NoGoLo2 / IRB00421624
- Conditions
- Pneumonia
- Keywords
- Pneumonia, High flow nasal cannula oxygen, Oxygen, Low and Middle Income Countries, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Dec 2023 (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.
The goal of this pilot clinical trial is to compare standard of care, low-flow oxygen, and high-flow nasal canula oxygen in pediatric patients aged 1-59 months with pneumonia and an oxygen saturation of 90-93% in Malawi. The main question it aims to answer is:
- Does the protocol for the randomized control trial work well?
- Can the researchers safely conduct the protocol for the trial?
Participants will be randomly assigned to one of the three groups (normal care without oxygen, low-flow oxygen, and high-flow nasal cannula oxygen) and treated with that therapy in the hospital. Researchers will look at the ability to safely conduct each part of the study.
Detailed description
Pneumonia is the leading infectious cause of under 5-year-old deaths globally and responsible for \>50% of deaths in Africa. The World Health Organization (WHO) defines low blood oxygen saturation (SpO2) levels (hypoxemia) as 90%. Hypoxemia is identified in 31% of child pneumonia cases in Africa and is a key marker of elevated mortality risk. When children are hypoxemic, the WHO recommends oxygen treatment. Importantly, the WHO threshold of 90% for hypoxemia was based on concerns over limited oxygen supply and hospital over-crowding in low- and middle-income countries (LMICs), rather than quality evidence. In most LMICs, low oxygen flow is the mainstay of oxygen delivery. Recently, in high-income settings high-flow nasal cannula (HFNC) oxygen has emerged as a safe and effective alternative. HFNC oxygen delivers higher flow warmed, humidified gas via nasal prongs to reverse hypoxemia, and potentially improve outcomes.
Recent evidence challenges whether the WHO \& 90% hypoxemia threshold is optimal for identifying all children at higher risk of mortality in LMICs. One meta-analysis from 13 LMICs reported 3.66-fold-higher odds of death (95% confidence interval (CI), 1.42, 9.47) for children with a SpO2 93%. The investigators research from Malawi and Bangladesh established children with pneumonia and SpO2 between 90-93% (moderate hypoxemia) is common, and, compared to higher SpO2 levels, conveys higher mortality risk. To date, African children with a SpO2 90-93% are not recommended for oxygen treatment. Observational data from Malawi found children with moderate hypoxemia and treated with oxygen had higher survival than those referred with a SpO2 90%. Currently, no randomized trials have determined whether low flow oxygen or HFNC oxygen treatment reduces the mortality of children with moderate hypoxemia (SpO2 90-93%) in African LMICs.
Aim 1: Conduct a pilot open label, three armed, parallel, randomized controlled trial (RCT) comparing standard care, low-flow oxygen, and HFNC oxygen for children with clinical pneumonia and a SpO2 90-93% to determine feasibility of a larger trial. The investigators hypothesize it will be feasible to recruit, randomize, treat, and safely follow-up all participants. Children with SpO2 90-93% will be randomized 1:1:1 to standard care without oxygen (controls), low flow oxygen (intervention #1), or HFNC oxygen (intervention #2). The primary outcome will be feasibility, defined as the proportion of enrolled children with 2 protocol violations. Secondary outcomes include consent refusal, intervention efficacy, participant attrition, and safety.
Aim 2: Determine the prevalence of young Malawian children with a SpO2 90-93% at the designated study hospital. The investigators hypothesize a SpO2 90-93% will be common among children presenting to the trial hospital. The investigators will measure the SpO2 of all children under-five years old (not limited to pneumonia cases) presenting to the hospital 1 week per month over 12-months. Conservatively assuming an average volume of 30 children per day, based on prior data, the investigators will generate 1,400 SpO2 measurements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot trial to assess feasibility of the protocol for a three-armed, open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will receive pneumonia care per World Health Organization guidelines. If their oxygen saturation falls below 90% after enrollment, they will be treated with low-flow oxygen. |
| Low-flow Oxygen | Experimental | Device: Low flow oxygenParticipants will be treated with low-flow oxygen to achieve a goal oxygen saturation above 94% |
| High-flow Nasal Cannula Oxygen | Experimental | Device: High-flow nasal cannula oxygenParticipants will be treated with high-flow nasal cannula oxygen to achieve a goal oxygen saturation above 94%. |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-59 months of age
- Pneumonia (as defined by the World Health Organization)
- Oxygen saturation 90-93% without oxygen
Key exclusion criteria (7 listed)
- Emergency signs (signs of severe illness as defined by the World Health Organization) including:
- absent or obstructed breathing,
- severe respiratory distress,
- shock,
- decreased mental status,
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 |
|---|---|---|
| Low flow oxygenStandard nasal cannula oxygen up to 2 liters/minute | Device | Low-flow Oxygen |
| High-flow nasal cannula oxygenHigh-flow nasal cannula with heating and humidification up to 2 liters/kilogram/minute | Device | High-flow Nasal Cannula Oxygen |
Primary outcome
Feasibility of study protocol as assessed by protocol violations
Time frame: Enrollment up to 14 days
Determine overall protocol fidelity, defined as the percentage of enrolled children with < 2 protocol violations, of an open-label, three arm randomized controlled trial comparing low-flow and high-flow nasal cannula (HFNC) oxygen to standard of care without oxygen therapy
6 secondary outcomes
Caregiver Trial Acceptability
Time frame: Day of screening and enrollment
Feasibility of screening and enrollment as assessed by percentage of inclusion and exclusion violations
Time frame: Day of screening and enrollment
Feasibility of randomization as assessed by percentage of children receiving intervention
Time frame: 1 hour after randomization
Fidelity to treatment failure study definition as assessed by percentage of children with correct treatment failure classification
Time frame: Enrollment up to 14 days
Fidelity to respiratory supportive care protocol as assessed by percentage of children without a respiratory support protocol violation
Time frame: Enrollment up to 14 days
Feasibility of at home follow up as assessed by percentage of participants followed up at home
Time frame: Enrollment up to 14 days
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 20 Dec 2024.
- Background: PubMed 34086669Tortosa F, Izcovich A, Carrasco G, Varone G, Haluska P, Sanguine V. High-flow oxygen nasal cannula for treating acute bronchiolitis in infants: A systematic review and meta-analysis. Medwave. 2021 May 12;21(4):e8190. doi: 10.5867/medwave.2021.04.8190. English, Spanish.
- Background: PubMed 31570155Luo J, Duke T, Chisti MJ, Kepreotes E, Kalinowski V, Li J. Efficacy of High-Flow Nasal Cannula vs Standard Oxygen Therapy or Nasal Continuous Positive Airway Pressure in Children with Respiratory Distress: A Meta-Analysis. J Pediatr. 2019 Dec;215:199-208.e8. doi: 10.1016/j.jpeds.2019.07.059. Epub 2019 Sep 27.
- Background: PubMed 30655267Lin J, Zhang Y, Xiong L, Liu S, Gong C, Dai J. High-flow nasal cannula therapy for children with bronchiolitis: a systematic review and meta-analysis. Arch Dis Child. 2019 Jun;104(6):564-576. doi: 10.1136/archdischild-2018-315846. Epub 2019 Jan 17.
- Background: PubMed 27741041Kawaguchi A, Yasui Y, deCaen A, Garros D. The Clinical Impact of Heated Humidified High-Flow Nasal Cannula on Pediatric Respiratory Distress. Pediatr Crit Care Med. 2017 Feb;18(2):112-119. doi: 10.1097/PCC.0000000000000985.
- 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 32232547Moreel L, Proesmans M. High flow nasal cannula as respiratory support in treating infant bronchiolitis: a systematic review. Eur J Pediatr. 2020 May;179(5):711-718. doi: 10.1007/s00431-020-03637-0. Epub 2020 Mar 31.
- Background: PubMed 25452315Hutchings FA, Hilliard TN, Davis PJ. Heated humidified high-flow nasal cannula therapy in children. Arch Dis Child. 2015 Jun;100(6):571-5. doi: 10.1136/archdischild-2014-306590. Epub 2014 Dec 1.
- Background: PubMed 31562059McCollum ED, Mvalo T, Eckerle M, Smith AG, Kondowe D, Makonokaya D, Vaidya D, Billioux V, Chalira A, Lufesi N, Mofolo I, Hosseinipour M. Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial. Lancet Respir Med. 2019 Nov;7(11):964-974. doi: 10.1016/S2213-2600(19)30243-7. Epub 2019 Sep 24.
- Background: PubMed 31008520Chaparro CM, Suchdev PS. Anemia epidemiology, pathophysiology, and etiology in low- and middle-income countries. Ann N Y Acad Sci. 2019 Aug;1450(1):15-31. doi: 10.1111/nyas.14092. Epub 2019 Apr 22.
- Background: PubMed 31054779Allardet-Servent J, Sicard G, Metz V, Chiche L. Benefits and risks of oxygen therapy during acute medical illness: Just a matter of dose! Rev Med Interne. 2019 Oct;40(10):670-676. doi: 10.1016/j.revmed.2019.04.003. Epub 2019 May 1.
- Background: PubMed 32873404McCollum ED, Ahmed S, Roy AD, Chowdhury NH, Schuh HB, Rizvi SJR, Hanif AAM, Khan AM, Mahmud A, Pervaiz F, Harrison M, Reller ME, Simmons N, Quaiyum A, Begum N, Santosham M, Checkley W, Moulton LH, Baqui AH; Projahnmo Study Group in Bangladesh. Effectiveness of the 10-valent pneumococcal conjugate vaccine against radiographic pneumonia among children in rural Bangladesh: A case-control study. Vaccine. 2020 Sep 29;38(42):6508-6516. doi: 10.1016/j.vaccine.2020.08.035. Epub 2020 Aug 29.
- Background: PubMed 33095763Colbourn T, King C, Beard J, Phiri T, Mdala M, Zadutsa B, Makwenda C, Costello A, Lufesi N, Mwansambo C, Nambiar B, Hooli S, French N, Bar Zeev N, Qazi SA, Bin Nisar Y, McCollum ED. Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: A data linkage study. PLoS Med. 2020 Oct 23;17(10):e1003300. doi: 10.1371/journal.pmed.1003300. eCollection 2020 Oct.
- Individual participant dataSharing planned: Yes. The research proposed is a pilot randomized, open-label trial of acute lower respiratory infection with moderate hypoxemia oxygen use in Malawi. The pilot trial will enroll 21 participants with a primary outcome of study feasibility. The datasets will report de-identified patient outcomes including mortality, hospital length of stay, and treatment failure as well as trial feasibility and acceptability data. The shared format of data will be .csv files.
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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.
Eric E McCollom, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow oxygen and High-flow nasal cannula oxygen in people with Pneumonia, run by Johns Hopkins University at 1 site in Malawi.
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 3 inclusion and 7 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 20 Dec 2024. 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 Malawi. 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?
Feasibility of study protocol as assessed by protocol violations (time frame: Enrollment up to 14 days). 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 NCT06176664, 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 20 Dec 2024.