<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/NCT03306004</url>
  </required_header>
  <id_info>
    <org_study_id>HSR 16_2172x</org_study_id>
    <nct_id>NCT03306004</nct_id>
  </id_info>
  <brief_title>Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho</brief_title>
  <acronym>4NNJ</acronym>
  <official_title>Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hennepin Healthcare Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine the knowledge attitude and practices of all levels of health care providers about&#xD;
      neonatal jaundice&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the routine post-natal visit, trained research personnel will inform the mother of the&#xD;
      infant or medical practitioner that a study in being carried out to better understand the&#xD;
      knowledge, attitudes and practices of mothers and health care providers for neonatal&#xD;
      jaundice. The investigators will then proceed to ask the mothers or health care professionals&#xD;
      if they would be interested in filling out an anonymous survey that will assess their&#xD;
      knowledge of neonatal jaundice and their practices, if any, in caring for this condition. No&#xD;
      PHI will be included and no written consent will be obtained as the written consent would be&#xD;
      the only link to the person participating in the survey. Verbal consent will be obtained and&#xD;
      we will explain that their medical care and care of the children will in no way be affected&#xD;
      by their answers to the survey. We will carefully explain that their participation in the&#xD;
      survey is voluntary.&#xD;
&#xD;
      For medical students, they will be informed that a study is being carried out to better&#xD;
      understand the knowledge, attitudes and practices of medical trainees for neonatal jaundice.&#xD;
      They will then be asked if they would be interested in filling out an anonymous survey that&#xD;
      assess their knowledge of neonatal jaundice, and their practices, if any, in caring for this&#xD;
      condition. No PHI will be included and no written consent will be obtained, as the written&#xD;
      consent would be the only link to the person participating in the survey. Verbal consent will&#xD;
      be obtained and we will explain that their academic standing will not be affected by their&#xD;
      answers to the survey. We will carefully explain that their participation in the survey is&#xD;
      voluntary.&#xD;
&#xD;
      All surveys will contain the names and contact information of the investigators.&#xD;
&#xD;
      The survey will be administered under the direction of the researchers by the researchers&#xD;
      and/or their trained research team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of Jaundice</measure>
    <time_frame>Baseline</time_frame>
    <description>Assess the knowledge of health care and mothers regarding jaundice in neonates using a multi choice survey with approximately 40 questions.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">360</enrollment>
  <condition>Neonatal Jaundice</condition>
  <arm_group>
    <arm_group_label>Health Care Providers</arm_group_label>
    <description>Providers answer questionaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mothers</arm_group_label>
    <description>Mothers answer questionaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionare</intervention_name>
    <arm_group_label>Health Care Providers</arm_group_label>
    <arm_group_label>Mothers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Health Care providers and Mothers with neonates in for routine childcare visits&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Mothers and Health Care Workers willing to fill out survey in and around Ogbomoso,&#xD;
             Nigeria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All Mothers and Health Care Workers not willing to fill out survey in an around&#xD;
             Ogbomoso, Nigeria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bowen University Teaching Hospital</name>
      <address>
        <city>Ogbomoso</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice, Neonatal</mesh_term>
    <mesh_term>Jaundice</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03306004
org study id: HSR 16_2172x
nct id: NCT03306004
lead sponsor: 
collaborator: 
has dmc: No
Determine the knowledge attitude and practices of all levels of health care providers about
      neonatal jaundice
During the routine post-natal visit, trained research personnel will inform the mother of the
      infant or medical practitioner that a study in being carried out to better understand the
      knowledge, attitudes and practices of mothers and health care providers for neonatal
      jaundice. The investigators will then proceed to ask the mothers or health care professionals
      if they would be interested in filling out an anonymous survey that will assess their
      knowledge of neonatal jaundice and their practices, if any, in caring for this condition. No
      PHI will be included and no written consent will be obtained as the written consent would be
      the only link to the person participating in the survey. Verbal consent will be obtained and
      we will explain that their medical care and care of the children will in no way be affected
      by their answers to the survey. We will carefully explain that their participation in the
      survey is voluntary.

      For medical students, they will be informed that a study is being carried out to better
      understand the knowledge, attitudes and practices of medical trainees for neonatal jaundice.
      They will then be asked if they would be interested in filling out an anonymous survey that
      assess their knowledge of neonatal jaundice, and their practices, if any, in caring for this
      condition. No PHI will be included and no written consent will be obtained, as the written
      consent would be the only link to the person participating in the survey. Verbal consent will
      be obtained and we will explain that their academic standing will not be affected by their
      answers to the survey. We will carefully explain that their participation in the survey is
      voluntary.

      All surveys will contain the names and contact information of the investigators.

      The survey will be administered under the direction of the researchers by the researchers
      and/or their trained research team.
observational model: Other
time perspective: Prospective
measure: Knowledge of Jaundice
time frame: Baseline
description: Assess the knowledge of health care and mothers regarding jaundice in neonates using a multi choice survey with approximately 40 questions.
arm group label: Health Care Providers
description: Providers answer questionaires
arm group label: Mothers
description: Mothers answer questionaires
intervention type: Other
intervention name: Questionare
arm group label: Health Care Providers
arm group label: Mothers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Nigeria
responsible party type: Sponsor
mesh term: Jaundice, Neonatal
mesh term: Jaundice
sharing ipd: No