<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/NCT01676610</url>
  </required_header>
  <id_info>
    <org_study_id>1000028096</org_study_id>
    <nct_id>NCT01676610</nct_id>
  </id_info>
  <brief_title>Infant Pulse Oximetry in Pakistan Study</brief_title>
  <acronym>iPOP</acronym>
  <official_title>Infant Pulse Oximetry in Pakistan (iPOP) Study: Utility and Feasibility of Integrating Pulse Oximetry Into the Routine Assessment of Young Infants at First-level Clinics in Karachi, Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign&#xD;
      of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid,&#xD;
      portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation&#xD;
      (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting.&#xD;
      In this research study, we propose to test the hypothesis that the use of pulse oximetry to&#xD;
      detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible&#xD;
      for the identification of the infants most urgently in need of medical care. We will enroll&#xD;
      1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi.&#xD;
      Infants will undergo brief clinical assessment by a community health worker (CHW) based on&#xD;
      the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm,&#xD;
      assessment by two pulse oximetry devices, and examination by a physician. The primary&#xD;
      outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain&#xD;
      measurement, number of infants for who repeat measurements are required), and concordance&#xD;
      between paired measurements on separate devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of hypoxemia</measure>
    <time_frame>Over the duration of hopsital stay, on average 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validity of PO</measure>
    <time_frame>Baseline, +2 hours</time_frame>
    <description>Validity of PO for the detection of infant illness, in comparison to physician assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of PO Measurements</measure>
    <time_frame>Baseline, +2 hours</time_frame>
    <description>Between-devices comparison of PO measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operational Feasibility</measure>
    <time_frame>Baseline, +2 hours</time_frame>
    <description>Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3149</enrollment>
  <condition>Hypoxemia</condition>
  <condition>Neonatal Sepsis</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Infants presenting to the Clinic</arm_group_label>
    <description>Infants presenting to the Bilal and Bhains Colony Health Center. Devices used to measure Pulse Oximetry (PO) include Rad-5v by Masimo, TuffSat by GE, N-65 by Nellcor, PRO2 by Conmed, and Lifebox by Acare.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Young infants, aged 0-59 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan&#xD;
&#xD;
          -  Age 0 - 59 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>59 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Roth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>May 21, 2014</last_update_submitted>
  <last_update_submitted_qc>May 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Daniel Roth</investigator_full_name>
    <investigator_title>Staff Physician, Paediatric Medicine</investigator_title>
  </responsible_party>
  <keyword>Pulse Oximetry</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Pakistan</keyword>
  <keyword>Hypoxemia</keyword>
  <keyword>Neonatal Sepsis</keyword>
  <keyword>Pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Neonatal Sepsis</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01676610
org study id: 1000028096
nct id: NCT01676610
lead sponsor: 
has dmc: No
Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign
      of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid,
      portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation
      (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting.
      In this research study, we propose to test the hypothesis that the use of pulse oximetry to
      detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible
      for the identification of the infants most urgently in need of medical care. We will enroll
      1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi.
      Infants will undergo brief clinical assessment by a community health worker (CHW) based on
      the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm,
      assessment by two pulse oximetry devices, and examination by a physician. The primary
      outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain
      measurement, number of infants for who repeat measurements are required), and concordance
      between paired measurements on separate devices.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of hypoxemia
time frame: Over the duration of hopsital stay, on average 24 hours
measure: Validity of PO
time frame: Baseline, +2 hours
description: Validity of PO for the detection of infant illness, in comparison to physician assessment.
measure: Comparison of PO Measurements
time frame: Baseline, +2 hours
description: Between-devices comparison of PO measurements
measure: Operational Feasibility
time frame: Baseline, +2 hours
description: Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
arm group label: Infants presenting to the Clinic
description: Infants presenting to the Bilal and Bhains Colony Health Center. Devices used to measure Pulse Oximetry (PO) include Rad-5v by Masimo, TuffSat by GE, N-65 by Nellcor, PRO2 by Conmed, and Lifebox by Acare.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 59 Days
healthy volunteers: No
last name: Daniel Roth, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
country: Canada
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Daniel Roth
investigator title: Staff Physician, Paediatric Medicine
mesh term: Pneumonia
mesh term: Neonatal Sepsis
mesh term: Hypoxia