<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750747</url>
  </required_header>
  <id_info>
    <org_study_id>PR-18054</org_study_id>
    <nct_id>NCT03750747</nct_id>
  </id_info>
  <brief_title>Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the feasibility, acceptability and operational&#xD;
      challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory&#xD;
      infections at first-level primary care facilities in Bangladesh (phase 1). The investigators&#xD;
      will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI&#xD;
      services at first level primary care health facilities (phase 2).&#xD;
&#xD;
      This study will employ a cluster randomized controlled trial design to evaluate the&#xD;
      effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility&#xD;
      assessment (phase-1 objective) will be nested within the larger effectiveness trail as&#xD;
      internal piloting; which will help in generating evidence for designing a robust phase-2&#xD;
      trial. First-level primary healthcare facilities providing IMCI services will be regarded as&#xD;
      clusters and the unit of randomization. Sixteen first level primary care health facilities&#xD;
      (UH&amp;FWC) will be randomly assigned to comparison and intervention facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        1. Burden: Pneumonia is the leading cause of childhood mortality which accounts for 16% of&#xD;
           all under-5 deaths in Bangladesh and globally. Most of these deaths happen in the&#xD;
           developing countries, where WHO recommends adopting Integrated Management of Childhood&#xD;
           Illness (IMCI) as a strategy for outpatient management of common childhood illnesses,&#xD;
           including pneumonia, in these poor resource settings.&#xD;
&#xD;
        2. Knowledge gap: As per the IMCI guidelines, 'Pneumonia' can be treated through home-based&#xD;
           management with oral antibiotics, whereas 'Severe Pneumonia' should be referred to&#xD;
           high-level facilities for inpatient care. Previously, chest indrawing was considered as&#xD;
           one of the signs of 'Severe Pneumonia.' In 2014, WHO revised the IMCI guidelines&#xD;
           recommending chest indrawing as a sign of 'Pneumonia' instead of 'Severe Pneumonia.' A&#xD;
           systematic review of the home-based management of chest indrawing 'Pneumonia' reported a&#xD;
           treatment failure rate of 8.5% on day 6. This implies that some of the chest indrawing&#xD;
           'Pneumonia' cases will require special inpatient care in addition to oral antibiotics&#xD;
           and home-based management as currently recommended by WHO.&#xD;
&#xD;
        3. Relevance: Hypoxemia (SpO2&lt;90%) is one of the strongest predictors of mortality due to&#xD;
           pneumonia. Many of the chest indrawing 'Pneumonia' cases may have hypoxemia and need&#xD;
           specialized inpatient care. In response to this, WHO recommended measuring SpO2 level&#xD;
           with pulse oximetry (PO) as a part of IMCI services. As per the updated IMCI guidelines,&#xD;
           any sick child (2-59 months) having SpO2 &lt;90% should be referred for inpatient&#xD;
           management, irrespective of its clinical classification. However, most of the primary&#xD;
           care facilities are devoid of PO; and there is a paucity of evidence related to the&#xD;
           feasibility and effectiveness of introducing of PO in primary care facilities.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  Phase-1: To assess the feasibility, acceptability and operational challenges of&#xD;
           introducing PO in IMCI services at first-level primary care health facilities in&#xD;
           Bangladesh&#xD;
&#xD;
        -  Phase-2: To evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI&#xD;
           services at first level primary care health facilities in Bangladesh&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This study will employ a cluster randomized controlled trial design to evaluate the&#xD;
      effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility&#xD;
      assessment (phase-1 objective) will be nested within the larger effectiveness trail as an&#xD;
      internal piloting; which will help in generating evidence for designing a robust phase-2&#xD;
      trial. First-level primary healthcare facilities providing IMCI services will be regarded as&#xD;
      clusters and the unit of randomization. Twenty-four first level primary care health&#xD;
      facilities will be randomly assigned to comparison and intervention facilities.&#xD;
&#xD;
      In phase-1, the feasibility, acceptability and operational challenges of introducing PO in&#xD;
      IMCI services will be assessed in the intervention facilities. Structured observation of the&#xD;
      use of PO in IMCI services and community case tracking will be conducted to address the&#xD;
      phase-1 objective. Rigorous process documentation and qualitative method of data collection&#xD;
      will be employed to document the process of implementation and assess implementation&#xD;
      outcomes.&#xD;
&#xD;
      In phase-2, effectiveness will be assessed through community case tracking in both comparison&#xD;
      and intervention facilities. Treatment failure rate will be the primary outcome and the&#xD;
      analysis will consider 'intention to treat' approach. In addition, activity-based costing&#xD;
      method will be adopted for collecting cost-related data.&#xD;
&#xD;
      Outcome measures/variables:&#xD;
&#xD;
      This study will assess the effectiveness of integrating PO in IMCI services in first-level&#xD;
      health facilities in Bangladesh. PO will be able to identify children who are classified as&#xD;
      'Pneumonia' based on history and clinical signs but have hypoxaemia. It will facilitate&#xD;
      referral of children with hypoxaemia to higher level facilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment failure rate</measure>
    <time_frame>up to 12 months</time_frame>
    <description>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:&#xD;
Death&#xD;
Appearance of any of the danger signs:&#xD;
Inability to drink&#xD;
Vomits everything&#xD;
Lethargy or unconsciousness&#xD;
Convulsions or history of convulsion&#xD;
Persistence of&#xD;
Low oxygen saturation (SpO2&lt;90%)&#xD;
Chest indrawing&#xD;
Fast breathing</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">612</enrollment>
  <condition>Childhood Pneumonia</condition>
  <condition>Hypoxemia</condition>
  <arm_group>
    <arm_group_label>Intervention (Pulse Oximeter)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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&lt;90% will be referred to higher-level facilities for in-patient management. Only the children clinically classified 'Pneumonia' and having SpO2&gt;90% will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Oximeter</intervention_name>
    <description>SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing &lt;10 kg, the sensor will be placed on the big toe. For patients weighing &gt;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.</description>
    <arm_group_label>Intervention (Pulse Oximeter)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sick children aged 2 to 59 months&#xD;
&#xD;
          2. Presenting with cough or difficult breathing&#xD;
&#xD;
          3. Receiving IMCI services in the selected facilities will be enrolled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severely ill children who need to be referred immediately&#xD;
&#xD;
          2. If the parents of the children are unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Ehsanur Rahman, MBBS, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shams El Arifeen, DrPH</last_name>
    <phone>+8801713366936</phone>
    <email>shams@icddrb.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research, Bangladesh</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <link>
    <url>http://apps.who.int/iris/bitstream/handle/10665/104772/9789241506823_Chartbook_eng.pdf;jsessionid=45058111AE386D954C19C57B8AD47E13?sequence=16</url>
    <description>World Health Organization. Integrated Management of Childhood Illness; Chart Booklet: WHO Library Cataloguin; 2014.</description>
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  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IMCI services</keyword>
  <keyword>Pulse Oximeter</keyword>
  <keyword>Acute respiratory infections</keyword>
  <keyword>Implementation research</keyword>
  <keyword>Hypoxaemia</keyword>
  <keyword>Childhood Pneumonia</keyword>
  <keyword>Resource poor settings</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750747
org study id: PR-18054
nct id: NCT03750747
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Treatment failure rate
time frame: up to 12 months
description: 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
arm group label: Intervention (Pulse Oximeter)
arm group type: Experimental
description: 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).
arm group label: Comparison
arm group type: No Intervention
description: 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)
intervention type: Device
intervention name: Pulse Oximeter
description: 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.
arm group label: Intervention (Pulse Oximeter)
criteria: 
gender: All
minimum age: 2 Months
maximum age: 59 Months
healthy volunteers: No
last name: Ahmed Ehsanur Rahman, MBBS, MPH
role: Principal Investigator
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
last name: Shams El Arifeen, DrPH
phone: +8801713366936
email: shams@icddrb.org
facility: 
status: Recruiting
country: Bangladesh
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responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Hypoxia
sharing ipd: No
ipd 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.