Oxygen Therapy for Children With Moderate Hypoxemia in Malawi
NCT ID: NCT06176664
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2024-05-15
2024-11-30
Brief Summary
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* 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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standard of Care
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.
No interventions assigned to this group
Low-flow Oxygen
Participants will be treated with low-flow oxygen to achieve a goal oxygen saturation above 94%
Low flow oxygen
Standard nasal cannula oxygen up to 2 liters/minute
High-flow Nasal Cannula Oxygen
Participants will be treated with high-flow nasal cannula oxygen to achieve a goal oxygen saturation above 94%.
High-flow nasal cannula oxygen
High-flow nasal cannula with heating and humidification up to 2 liters/kilogram/minute
Interventions
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Low flow oxygen
Standard nasal cannula oxygen up to 2 liters/minute
High-flow nasal cannula oxygen
High-flow nasal cannula with heating and humidification up to 2 liters/kilogram/minute
Eligibility Criteria
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Inclusion Criteria
* Pneumonia (as defined by the World Health Organization)
* Oxygen saturation 90-93% without oxygen
Exclusion Criteria
* absent or obstructed breathing,
* severe respiratory distress,
* shock,
* decreased mental status,
* convulsions, or
* severe dehydration
1 Month
59 Months
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Eric E McCollom, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Salima District Hospital
Salima, Central Region, Malawi
Countries
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References
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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.
Luo 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.
Lin 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.
Kawaguchi 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.
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Moreel 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.
Hutchings 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.
McCollum 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.
Chaparro 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.
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McCollum 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.
Colbourn 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.
Rahman 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.
McCollum 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.
Hooli 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.
Hooli S, King C, Zadutsa B, Nambiar B, Makwenda C, Masache G, Lufesi N, Mwansambo C, Malla L, Costello A, Colbourn T, McCollum ED. The Epidemiology of Hypoxemic Pneumonia among Young Infants in Malawi. Am J Trop Med Hyg. 2020 Mar;102(3):676-683. doi: 10.4269/ajtmh.19-0516.
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Subhi R, Adamson M, Campbell H, Weber M, Smith K, Duke T; Hypoxaemia in Developing Countries Study Group. The prevalence of hypoxaemia among ill children in developing countries: a systematic review. Lancet Infect Dis. 2009 Apr;9(4):219-27. doi: 10.1016/S1473-3099(09)70071-4.
McCollum ED, Bjornstad E, Preidis GA, Hosseinipour MC, Lufesi N. Multicenter study of hypoxemia prevalence and quality of oxygen treatment for hospitalized Malawian children. Trans R Soc Trop Med Hyg. 2013 May;107(5):285-92. doi: 10.1093/trstmh/trt017.
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Other Identifiers
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IRB00421624
Identifier Type: -
Identifier Source: org_study_id