<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/NCT01688674</url>
  </required_header>
  <id_info>
    <org_study_id>2009/HD11/16712 U</org_study_id>
    <nct_id>NCT01688674</nct_id>
  </id_info>
  <brief_title>Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia</brief_title>
  <official_title>Dextrose Boluses Versus Dextrose Infusions by Burettes in Prevention of Hypoglycemia Among Preterms Admitted at Mulago Hospital: An Open Label Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms&#xD;
      receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during&#xD;
      the 72 hours of admission in Special Care Unit- Mulago Hospital.&#xD;
&#xD;
      ALTERNATE HYPOTHESIS&#xD;
&#xD;
      • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30%&#xD;
      compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in&#xD;
      the first 72 hours of admission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    There was more benefit from the infusion arm compared to the bolus arm.&#xD;
  </why_stopped>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence proportion of hypoglycemia</measure>
    <time_frame>3months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival measured as a proportion</measure>
    <time_frame>3months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.</condition>
  <arm_group>
    <arm_group_label>Bolus arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>two hourly dextrose boluses administered via an intravenous cannula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10% dextrose infusion by burettes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10% dextrose</intervention_name>
    <arm_group_label>Bolus arm</arm_group_label>
    <arm_group_label>infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - SELECTION CRITERIA Inclusion criteria&#xD;
&#xD;
          -  Preterms whose care givers/ mothers gave informed consent&#xD;
&#xD;
          -  Preterms whose age was &lt; 24 hours of life&#xD;
&#xD;
          -  Preterms with birth weight ≥1kg&#xD;
&#xD;
          -  Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Absence of a biological mother or abandoned baby&#xD;
&#xD;
          -  Presence of gross congenital abnormalities.&#xD;
&#xD;
          -  Very sick (Apgar score ≤ 5 at 5 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mulago Hospital</name>
      <address>
        <city>Kampala</city>
        <state>Mulago</state>
        <zip>+256</zip>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makerere University</investigator_affiliation>
    <investigator_full_name>KUTAMBA ELIZABETH</investigator_full_name>
    <investigator_title>Elizabeth Kutamba.R</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hypoglycemia</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/NCT01688674
org study id: 2009/HD11/16712 U
nct id: NCT01688674
lead sponsor: 
has dmc: Yes
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms
      receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during
      the 72 hours of admission in Special Care Unit- Mulago Hospital.

      ALTERNATE HYPOTHESIS

      • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30%
      compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in
      the first 72 hours of admission.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence proportion of hypoglycemia
time frame: 3months
measure: survival measured as a proportion
time frame: 3months
arm group label: Bolus arm
arm group type: Placebo Comparator
description: two hourly dextrose boluses administered via an intravenous cannula
arm group label: infusion
arm group type: Experimental
description: 10% dextrose infusion by burettes
intervention type: Drug
intervention name: 10% dextrose
arm group label: Bolus arm
arm group label: infusion
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Hours
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Makerere University
investigator full name: KUTAMBA ELIZABETH
investigator title: Elizabeth Kutamba.R
mesh term: Premature Birth
mesh term: Hypoglycemia