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Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services

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ClinicalTrials.gov Identifier: NCT03750747
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE November 22, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
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:
  • Death
  • Appearance of any of the danger signs:
    • Inability to drink
    • Vomits everything
    • Lethargy or unconsciousness
    • Convulsions or history of convulsion
  • Persistence of
    • Low oxygen saturation (SpO2<90%)
    • Chest indrawing
    • Fast breathing
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03750747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services
Official Title  ICMJE Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh
Brief Summary

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.

Detailed Description

Background:

  1. 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.
  2. 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.
  3. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Childhood Pneumonia
  • Hypoxemia
Intervention  ICMJE Device: Pulse Oximeter
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.
Study Arms  ICMJE
  • 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).
    Intervention: Device: Pulse Oximeter
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
612
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Sick children aged 2 to 59 months
  2. Presenting with cough or difficult breathing
  3. Receiving IMCI services in the selected facilities will be enrolled

Exclusion Criteria:

  1. Severely ill children who need to be referred immediately
  2. If the parents of the children are unwilling to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shams El Arifeen, DrPH +8801713366936 shams@icddrb.org
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03750747
Other Study ID Numbers  ICMJE PR-18054
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Confidentiality of the data will be ensured at all steps of the study including data collection, data management, access to data and use of the information. All personal identifiers will be removed from the data prior to analysis.
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE University of Edinburgh
Investigators  ICMJE
Principal Investigator: Ahmed Ehsanur Rahman, MBBS, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP