- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03750747
Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services
Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh
The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). The investigators will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities (phase 2).
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH&FWC) will be randomly assigned to comparison and intervention facilities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
- Burden: Pneumonia is the leading cause of childhood mortality which accounts for 16% of all under-5 deaths in Bangladesh and globally. Most of these deaths happen in the developing countries, where WHO recommends adopting Integrated Management of Childhood Illness (IMCI) as a strategy for outpatient management of common childhood illnesses, including pneumonia, in these poor resource settings.
- Knowledge gap: As per the IMCI guidelines, 'Pneumonia' can be treated through home-based management with oral antibiotics, whereas 'Severe Pneumonia' should be referred to high-level facilities for inpatient care. Previously, chest indrawing was considered as one of the signs of 'Severe Pneumonia.' In 2014, WHO revised the IMCI guidelines recommending chest indrawing as a sign of 'Pneumonia' instead of 'Severe Pneumonia.' A systematic review of the home-based management of chest indrawing 'Pneumonia' reported a treatment failure rate of 8.5% on day 6. This implies that some of the chest indrawing 'Pneumonia' cases will require special inpatient care in addition to oral antibiotics and home-based management as currently recommended by WHO.
- Relevance: Hypoxemia (SpO2<90%) is one of the strongest predictors of mortality due to pneumonia. Many of the chest indrawing 'Pneumonia' cases may have hypoxemia and need specialized inpatient care. In response to this, WHO recommended measuring SpO2 level with pulse oximetry (PO) as a part of IMCI services. As per the updated IMCI guidelines, any sick child (2-59 months) having SpO2 <90% should be referred for inpatient management, irrespective of its clinical classification. However, most of the primary care facilities are devoid of PO; and there is a paucity of evidence related to the feasibility and effectiveness of introducing of PO in primary care facilities.
Objectives:
- Phase-1: To assess the feasibility, acceptability and operational challenges of introducing PO in IMCI services at first-level primary care health facilities in Bangladesh
- Phase-2: To evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities in Bangladesh
Methods:
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as an internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Twenty-four first level primary care health facilities will be randomly assigned to comparison and intervention facilities.
In phase-1, the feasibility, acceptability and operational challenges of introducing PO in IMCI services will be assessed in the intervention facilities. Structured observation of the use of PO in IMCI services and community case tracking will be conducted to address the phase-1 objective. Rigorous process documentation and qualitative method of data collection will be employed to document the process of implementation and assess implementation outcomes.
In phase-2, effectiveness will be assessed through community case tracking in both comparison and intervention facilities. Treatment failure rate will be the primary outcome and the analysis will consider 'intention to treat' approach. In addition, activity-based costing method will be adopted for collecting cost-related data.
Outcome measures/variables:
This study will assess the effectiveness of integrating PO in IMCI services in first-level health facilities in Bangladesh. PO will be able to identify children who are classified as 'Pneumonia' based on history and clinical signs but have hypoxaemia. It will facilitate referral of children with hypoxaemia to higher level facilities.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shams El Arifeen, DrPH
- Phone Number: +8801713366936
- Email: shams@icddrb.org
Study Locations
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Dhaka, Bangladesh, 1212
- Recruiting
- International Centre for Diarrhoeal Disease Research, Bangladesh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sick children aged 2 to 59 months
- Presenting with cough or difficult breathing
- Receiving IMCI services in the selected facilities will be enrolled
Exclusion Criteria:
- Severely ill children who need to be referred immediately
- If the parents of the children are unwilling to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention (Pulse Oximeter)
The intervention facilities will provide IMCI services with PO in addition to following existing IMCI guidelines.
The IMCI service providers will classify and treat children presenting with cough and difficult breathing based on history and clinical signs.
In addition, they will use PO to measure the SpO2 status of the sick children.
Children clinically classified as 'Pneumonia' but having SpO2<90% will be referred to higher-level facilities for in-patient management.
Only the children clinically classified 'Pneumonia' and having SpO2>90% will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day).
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SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor.
For patients weighing <10 kg, the sensor will be placed on the big toe.
For patients weighing >10 kg, the sensor will be placed on an index finger.
In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt).
First, the sensor will be placed on toe or index finger and then the PO will be powered-on.
A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal).
Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.
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NO_INTERVENTION: Comparison
The comparison facilities will continue providing routine IMCI services as per the existing guidelines.
In routine IMCI services, IMCI service providers classify and treat children presenting with cough and difficult breathing based on history and clinical signs only.
In routine IMCI services in Bangladesh, PO has not been introduced.
Therefore, in the comparison facilities all children clinically classified as 'Pneumonia' will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment failure rate
Time Frame: up to 12 months
|
The primary outcome of interest is treatment failure rate among those who are clinically classified as 'Pneumonia'. Operational definition of treatment failure will be finalized based on expert consultation and opinion of the caretakers of sick children through PPI. For illustrative purpose, an operational definition of the treatment failure is presented below which is based on some similar studies, i.e. SAT, AFRINEST, NO-SHOT, etc.Presence of any of the followings signs on day-6 and day-12 will be a considered as treatment failure:
|
up to 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ahmed Ehsanur Rahman, MBBS, MPH, International Centre for Diarrhoeal Disease Research, Bangladesh
Publications and helpful links
General Publications
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- Fox MP, Thea DM, Sadruddin S, Bari A, Bonawitz R, Hazir T, Bin Nisar Y, Qazi SA; Pneumonia Studies Group. Low rates of treatment failure in children aged 2-59 months treated for severe pneumonia: a multisite pooled analysis. Clin Infect Dis. 2013 Apr;56(7):978-87. doi: 10.1093/cid/cis1201. Epub 2012 Dec 21.
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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.
- Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
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- Floyd J, Wu L, Hay Burgess D, Izadnegahdar R, Mukanga D, Ghani AC. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528(7580):S53-9. doi: 10.1038/nature16043.
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- Pedersen T, Dyrlund Pedersen B, Moller AM. Pulse oximetry for perioperative monitoring. Cochrane Database Syst Rev. 2003;(3):CD002013. doi: 10.1002/14651858.CD002013.
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- Dildy GA, van den Berg PP, Katz M, Clark SL, Jongsma HW, Nijhuis JG, Loucks CA. Intrapartum fetal pulse oximetry: fetal oxygen saturation trends during labor and relation to delivery outcome. Am J Obstet Gynecol. 1994 Sep;171(3):679-84. doi: 10.1016/0002-9378(94)90081-7.
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Helpful Links
- World Health Organization. Integrated Management of Childhood Illness; Chart Booklet: WHO Library Cataloguin; 2014.
- Hauri AM, Armstrong GL, HUTiN YJ. Contaminated injections in health care settings. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors Geneva: World Health Organization. 2003.
- World Health Organization. Revised WHO classification and treatment of pneumonia in children at health facilities: evidence summaries. 2014.
- Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations
- Rall G. Use of a pulse oxymetry sensor device. Google Patents; 1999.
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Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-18054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Pulse Oximeter
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William Beaumont HospitalsCompletedAsthma in Children | Respiratory Disease | Bronchiolitis Acute | Pneumonia in ChildrenUnited States
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Movano HealthUniversity of California, San FranciscoCompleted
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Nihon KohdenUniversity of California, San FranciscoActive, not recruiting
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Flashback TechnologiesDuke UniversityCompleted
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Nonin Medical, IncClinimark, LLCCompleted
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Nihon KohdenUniversity of California, San FranciscoCompleted
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Nihon KohdenUniversity of California, San FranciscoActive, not recruiting
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The Lifebox FoundationJohns Hopkins University; University College, London; Bill and Melinda Gates... and other collaboratorsCompletedPneumonia in Children | Measurement of Peripheral Oxygen SaturationUnited Kingdom, Bangladesh, Malawi
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Belun Technology Company LimitedClinimark, LLCCompleted