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Trial record 5 of 7 for:    strength | ( Map: Bangladesh )

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

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.


Condition or disease Intervention/treatment Phase
Childhood Pneumonia Hypoxemia Device: Pulse Oximeter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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).
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.

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)



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750747


Contacts
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Contact: Shams El Arifeen, DrPH +8801713366936 shams@icddrb.org

Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Edinburgh
Investigators
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Principal Investigator: Ahmed Ehsanur Rahman, MBBS, MPH International Centre for Diarrhoeal Disease Research, Bangladesh

Additional Information:
Publications:

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03750747     History of Changes
Other Study ID Numbers: PR-18054
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
IMCI services
Pulse Oximeter
Acute respiratory infections
Implementation research
Hypoxaemia
Childhood Pneumonia
Resource poor settings

Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Infection
Signs and Symptoms, Respiratory
Signs and Symptoms