<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/NCT03306316</url>
  </required_header>
  <id_info>
    <org_study_id>ColumbusCRI</org_study_id>
    <nct_id>NCT03306316</nct_id>
    <nct_alias>NCT04718662</nct_alias>
  </id_info>
  <brief_title>Prebiotic in Preterm Infants</brief_title>
  <official_title>The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 is a double blinded, randomized, controlled trial of prebiotic in infants born between&#xD;
      26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in&#xD;
      total and for the study to be completed in 18 months. The investigators anticipate collecting&#xD;
      clinical data, anthropometrics, stool samples (requiring appropriate storage through&#xD;
      analysis), salivary samples from mother and infant, discarded blood samples from baby after&#xD;
      the standard care lab tests are done, a single, optional blood draw at the conclusion of the&#xD;
      study, and subjecting infants to a neurodevelopmental survey at study completion.&#xD;
&#xD;
      The overall goal of this study is to test prebiotic administration to human milk-fed infants&#xD;
      who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through&#xD;
      one primary aim, a secondary aim, and exploratory aims, indicated below:&#xD;
&#xD;
      Primary aim: Compare weight, length, and head circumference Z-score growth between the study&#xD;
      and placebo groups.&#xD;
&#xD;
      Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more)&#xD;
      between the study and placebo groups.&#xD;
&#xD;
      Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive&#xD;
      care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.&#xD;
&#xD;
      Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of&#xD;
      supplementation on reducing intestinal inflammation between the study and placebo groups.&#xD;
&#xD;
      Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to&#xD;
      determine whether there is a shift in microbial composition towards bifidobacteria and other&#xD;
      microbes that are capable of metabolizing prebiotic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 4, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 1, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare length</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head Circumference</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare head circumference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adaptation</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare time to enteral autonomy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Neurobehavior</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare Neonatal intensive care unit Network Neurobehavioral Scale score</description>
  </other_outcome>
  <other_outcome>
    <measure>Gut inflammation</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare gut inflammation by measurement of fecal calprotectin</description>
  </other_outcome>
  <other_outcome>
    <measure>Fecal microbiome</measure>
    <time_frame>Enrollment through study day 45</time_frame>
    <description>Compare fecal microbiome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Preterm Infant</condition>
  <condition>Development, Infant</condition>
  <condition>Nutrition</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Control Arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prebiotic</intervention_name>
    <description>Prebiotic experimental group</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Study product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dextrose Control</intervention_name>
    <description>Dextrose Control</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants who meet the following inclusion criteria will be eligible for&#xD;
             randomization:&#xD;
&#xD;
               1. Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and&#xD;
                  &gt;/=26 weeks to 31 6/7 weeks.&#xD;
&#xD;
               2. Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an&#xD;
                  informed consent form (ICF). They have also provided Health Insurance Portability&#xD;
                  and Accountability Act (HIPAA) (or other applicable privacy regulation)&#xD;
                  authorization prior to any participation in the study.&#xD;
&#xD;
               3. Signed consent is obtained by day 10 after birth.&#xD;
&#xD;
               4. Mother plans to provide her own milk or consents to use of donor human milk in&#xD;
                  NICU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with the following conditions or situations at the time of randomization will&#xD;
             be excluded from the study:&#xD;
&#xD;
               1. Subject has known congenital anomalies.&#xD;
&#xD;
               2. Administration of enteral clinical product must be initiated by 9 ± 2 days of&#xD;
                  life (birth date is day of life 0).&#xD;
&#xD;
               3. Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or&#xD;
                  confirmed sepsis (positive culture requiring antibiotic treatment).&#xD;
&#xD;
               4. Steroid use at time of randomization&#xD;
&#xD;
               5. Mechanical ventilator dependence.&#xD;
&#xD;
               6. &gt;2 days of antimicrobial use prior to enrollment&#xD;
&#xD;
               7. Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during&#xD;
                  pregnancy or current&#xD;
&#xD;
               8. Mother or infant is currently receiving treatment consistent with HIV therapy.&#xD;
&#xD;
               9. Mother plans to formula feed exclusively and has not consented to use of donor&#xD;
                  milk during NICU stay.&#xD;
&#xD;
              10. Infant with intraventricular hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>10 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital and affiliated NICUs</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ethan Mezoff</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03306316
org study id: ColumbusCRI
nct id: NCT03306316
nct alias: NCT04718662
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a double blinded, randomized, controlled trial of prebiotic in infants born between
      26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in
      total and for the study to be completed in 18 months. The investigators anticipate collecting
      clinical data, anthropometrics, stool samples (requiring appropriate storage through
      analysis), salivary samples from mother and infant, discarded blood samples from baby after
      the standard care lab tests are done, a single, optional blood draw at the conclusion of the
      study, and subjecting infants to a neurodevelopmental survey at study completion.

      The overall goal of this study is to test prebiotic administration to human milk-fed infants
      who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through
      one primary aim, a secondary aim, and exploratory aims, indicated below:

      Primary aim: Compare weight, length, and head circumference Z-score growth between the study
      and placebo groups.

      Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more)
      between the study and placebo groups.

      Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive
      care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.

      Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of
      supplementation on reducing intestinal inflammation between the study and placebo groups.

      Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to
      determine whether there is a shift in microbial composition towards bifidobacteria and other
      microbes that are capable of metabolizing prebiotic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Weight
time frame: Enrollment through study day 45
description: Compare weight
measure: Length
time frame: Enrollment through study day 45
description: Compare length
measure: Head Circumference
time frame: Enrollment through study day 45
description: Compare head circumference
measure: Adaptation
time frame: Enrollment through study day 45
description: Compare time to enteral autonomy
measure: Neurobehavior
time frame: Enrollment through study day 45
description: Compare Neonatal intensive care unit Network Neurobehavioral Scale score
measure: Gut inflammation
time frame: Enrollment through study day 45
description: Compare gut inflammation by measurement of fecal calprotectin
measure: Fecal microbiome
time frame: Enrollment through study day 45
description: Compare fecal microbiome
arm group label: Experimental
arm group type: Experimental
description: Experimental Arm
arm group label: Control
arm group type: Placebo Comparator
description: Placebo Control Arm
intervention type: Dietary Supplement
intervention name: Prebiotic
description: Prebiotic experimental group
arm group label: Experimental
other name: Study product
intervention type: Dietary Supplement
intervention name: Dextrose Control
description: Dextrose Control
arm group label: Control
criteria: 
gender: All
minimum age: 7 Days
maximum age: 10 Days
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Ethan Mezoff
investigator title: Assistant Professor of Clinical Pediatrics
mesh term: Premature Birth
sharing ipd: No