<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/NCT03761498</url>
  </required_header>
  <id_info>
    <org_study_id>STU 042018-061</org_study_id>
    <nct_id>NCT03761498</nct_id>
  </id_info>
  <brief_title>Is There a Microbiome Associated With Poor Growth in Preterm Infants?</brief_title>
  <official_title>Is There a Microbiome Associated With Poor Growth in Preterm Infants?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      This study evaluates the relationship between growth and stool microbiota in premature&#xD;
      infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm infants often require increased caloric intake to maintain appropriate growth while&#xD;
      in the neonatal intensive care unit (NICU). While some infants will have a clear source of&#xD;
      need for greater calories, it is often not obvious why others require increased available&#xD;
      calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut&#xD;
      microbiota may play a role in infant and childhood growth. We hypothesize that differences in&#xD;
      the microbial pattern in preterm infants is related to poor growth and need for increased&#xD;
      caloric intake. This may ultimately represent a therapeutic target to improve the growth of&#xD;
      preterm infants in the NICU. This study aims to describe the differences in microbiome which&#xD;
      may vary with growth pattern.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>quantitative rT-PCR of stool microbiome</measure>
    <time_frame>8-10 weeks depending on length of stay in NICU</time_frame>
    <description>alpha diversity of bacterial groups in normal growth vs. poor growth</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">118</enrollment>
  <condition>Growth Disorders</condition>
  <condition>Growth Failure</condition>
  <condition>Prematurity</condition>
  <arm_group>
    <arm_group_label>Normal Growth</arm_group_label>
    <description>Require less than or equal to 110 kcal/kg/day to maintain growth curve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slow Growth</arm_group_label>
    <description>Require more than 110 kcal/kg/day to maintain growth curve</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caloric Requirement</intervention_name>
    <description>Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.</description>
    <arm_group_label>Slow Growth</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Preterm infants born at less than 28 weeks gestation will be eligible from birth until&#xD;
        discharge. Infants with major congenital anomalies which alter growth patterns will be&#xD;
        excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infants &gt;27 weeks gestation. Infants with major congenital anomalies which may alter growth&#xD;
        patterns.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Parkland Hopsital and Health System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Katherine Anne Stumpf</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</mesh_term>
    <mesh_term>Failure to Thrive</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/NCT03761498
org study id: STU 042018-061
nct id: NCT03761498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the relationship between growth and stool microbiota in premature
      infants.
Preterm infants often require increased caloric intake to maintain appropriate growth while
      in the neonatal intensive care unit (NICU). While some infants will have a clear source of
      need for greater calories, it is often not obvious why others require increased available
      calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut
      microbiota may play a role in infant and childhood growth. We hypothesize that differences in
      the microbial pattern in preterm infants is related to poor growth and need for increased
      caloric intake. This may ultimately represent a therapeutic target to improve the growth of
      preterm infants in the NICU. This study aims to describe the differences in microbiome which
      may vary with growth pattern.
observational model: Cohort
time perspective: Prospective
measure: quantitative rT-PCR of stool microbiome
time frame: 8-10 weeks depending on length of stay in NICU
description: alpha diversity of bacterial groups in normal growth vs. poor growth
arm group label: Normal Growth
description: Require less than or equal to 110 kcal/kg/day to maintain growth curve
arm group label: Slow Growth
description: Require more than 110 kcal/kg/day to maintain growth curve
intervention type: Other
intervention name: Caloric Requirement
description: Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.
arm group label: Slow Growth
Stool samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Katherine Anne Stumpf
investigator title: Assistant Professor of Pediatrics
mesh term: Growth Disorders
mesh term: Failure to Thrive
sharing ipd: No