<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/NCT03020147</url>
  </required_header>
  <id_info>
    <org_study_id>BandimHP</org_study_id>
    <nct_id>NCT03020147</nct_id>
  </id_info>
  <brief_title>Low Birth Weight Follow-up</brief_title>
  <official_title>Follow-up of Low Birth Weight Cohort of 2008-2013</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bandim Health Project</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bandim Health Project</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Randomized Control Trail included 4,172 low-birth weight children between February 2008&#xD;
      and September 2013 in Bissau. The children who were included in the RCT and who are living in&#xD;
      the Bandim Health Project study area will be visited. The study assistants will ask about the&#xD;
      health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar&#xD;
      status of both child and parents will be checked.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality differences between group who received early BCG and late BCG</measure>
    <time_frame>up to 8 years of age</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality by parental scar status</measure>
    <time_frame>up to 8 years of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalization rate between early BCG and late BCG group</measure>
    <time_frame>last two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>consultation rate between early BCG and late BCG group</measure>
    <time_frame>last two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>medication use between early BCG and late BCG group</measure>
    <time_frame>last two weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>hospitalization based on parental scar status</measure>
    <time_frame>last two weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>consultations based on parental scar status</measure>
    <time_frame>last two weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>medication use based on parental scar status</measure>
    <time_frame>last two weeks</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1258</enrollment>
  <condition>Non Specific Effects of Vaccine</condition>
  <condition>Bacillus-Calmette-Guerin</condition>
  <condition>Low Birth Weight</condition>
  <condition>Maternal Immunisation</condition>
  <arm_group>
    <arm_group_label>early BCG</arm_group_label>
    <description>Children received BCG soon after their birth between 2008 and 2013.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>delayed BCG</arm_group_label>
    <description>Children received BCG when they are 2,5kg between 2008 and 2013.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children who participated in the low birth weight trial between 2008 and 2013.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation during the low birth weight BCG trial between 2008 and 2013.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not living in the Bandim Health Project's study area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bandim Health Project</name>
      <address>
        <city>Bissau</city>
        <state>Bissau Codex</state>
        <zip>1004</zip>
        <country>Guinea-Bissau</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea-Bissau</country>
  </location_countries>
  <reference>
    <citation>Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.</citation>
    <PMID>21673035</PMID>
  </reference>
  <reference>
    <citation>Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.</citation>
    <PMID>22189537</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 22, 2021</last_update_submitted>
  <last_update_submitted_qc>April 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</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>Body Weight</mesh_term>
    <mesh_term>Birth Weight</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/NCT03020147
org study id: BandimHP
nct id: NCT03020147
lead sponsor: 
has dmc: No
The Randomized Control Trail included 4,172 low-birth weight children between February 2008
      and September 2013 in Bissau. The children who were included in the RCT and who are living in
      the Bandim Health Project study area will be visited. The study assistants will ask about the
      health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar
      status of both child and parents will be checked.
observational model: Cohort
time perspective: Retrospective
measure: mortality differences between group who received early BCG and late BCG
time frame: up to 8 years of age
measure: mortality by parental scar status
time frame: up to 8 years of age
measure: hospitalization rate between early BCG and late BCG group
time frame: last two weeks
measure: consultation rate between early BCG and late BCG group
time frame: last two weeks
measure: medication use between early BCG and late BCG group
time frame: last two weeks
measure: hospitalization based on parental scar status
time frame: last two weeks
measure: consultations based on parental scar status
time frame: last two weeks
measure: medication use based on parental scar status
time frame: last two weeks
arm group label: early BCG
description: Children received BCG soon after their birth between 2008 and 2013.
arm group label: delayed BCG
description: Children received BCG when they are 2,5kg between 2008 and 2013.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Guinea-Bissau
citation: Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
PMID: 21673035
citation: Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
PMID: 22189537
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Birth Weight