<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/NCT01674478</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00021481</org_study_id>
    <nct_id>NCT01674478</nct_id>
  </id_info>
  <brief_title>Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies</brief_title>
  <acronym>EMLFO-2</acronym>
  <official_title>Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common&#xD;
      devastating gastrointestinal diseases in premature infants. These infants often need surgical&#xD;
      intervention to remove the dead bowel and create temporary enterostomies, resulting in short&#xD;
      bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction&#xD;
      to digest and absorb nutrients adequately.&#xD;
&#xD;
      These infants are often nourished primarily with parental nutrition (PN) which can lead to&#xD;
      many complications including PN-associated liver disease. However, with enteral feeding, the&#xD;
      remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral&#xD;
      fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty&#xD;
      acids (LCPUFA) being the most beneficial in promoting bowel adaptation.&#xD;
&#xD;
      Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.&#xD;
      Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and&#xD;
      increase weight gain in some SBS infants. WThe investigators will soon have completed a&#xD;
      randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled &quot;Early&#xD;
      Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with&#xD;
      Enterostomies&quot;. The preliminary data suggest that (a) by supplementing enteral ML/FO, we were&#xD;
      able to decrease the use of IL; (b) premature infants in the treatment group who received&#xD;
      ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and&#xD;
      better weight gain (g/day) after reanastomosis than those who received routine care in&#xD;
      control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in&#xD;
      the treatment group than the control group although the difference was not statistically&#xD;
      significant. Because the intervention consisted of both an increase in enteral fat intake as&#xD;
      well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in&#xD;
      the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat&#xD;
      intake. Therefore, the investigators have designed a next randomized clinical trial to&#xD;
      compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO&#xD;
      will result in decreased systemic inflammation, as indicated by blood levels of&#xD;
      inflammation-related proteins and indicators of oxidative stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In comparison to EMLFO trial, the EMLFO-2 study will modify the eligibility criteria to only&#xD;
      enroll the infants who have birthweight equal to or less than 1250 g with a jejunostomy or&#xD;
      ileostomy as the result of surgical treatment for small intestine perforation or NEC in order&#xD;
      to increase the homogeneity of patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">March 17, 2015</completion_date>
  <primary_completion_date type="Actual">March 17, 2015</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Serum Biomarkers of Inflammatory Cytokines</measure>
    <time_frame>2 years and 5 months</time_frame>
    <description>Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Serum Biomarkers of Oxidative Stress</measure>
    <time_frame>2 years and 5 months</time_frame>
    <description>Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Average Enteral Calorie (Total Calorie) Intake Before Reanast</measure>
    <time_frame>2 years and 5 months</time_frame>
    <description>To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Average Weight Gain (g/Day) After Reanastomosis</measure>
    <time_frame>2 years and 5 months</time_frame>
    <description>To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Prematurity</condition>
  <condition>Intestine Perforation</condition>
  <condition>Necrotizing Enterocolitis (NEC)</condition>
  <condition>Short Bowel Syndrome (SBS)</condition>
  <arm_group>
    <arm_group_label>Microlipid with fish oil group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microlipid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be given early enteral lipid supplementation only with Microlipid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Microlipid with fish oil</intervention_name>
    <description>Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
    <arm_group_label>Microlipid with fish oil group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Microlipid</intervention_name>
    <description>A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
    <arm_group_label>Microlipid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. infants (age range: newborn to ≤ 2-month-old) whose birth weight are ≤ 1250g;&#xD;
&#xD;
          2. who are admitted to BCH NICU for surgical intervention for NEC or small intestine&#xD;
             perforation and then to have a jejunostomy or ileostomy;&#xD;
&#xD;
          3. who are expected to need full or partial PN for at least 21days from the day of ostomy&#xD;
             placement; and&#xD;
&#xD;
          4. who have received enteral feedings ≤ 4 days since ostomy placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. infant with birth weight &gt; 1250g;&#xD;
&#xD;
          2. infant with colostomy;&#xD;
&#xD;
          3. infants with enterostomy but&#xD;
&#xD;
               -  unable to obtain written informed consent from parent;&#xD;
&#xD;
               -  presence of congenital liver, renal, or metabolic diseases or syndromes or&#xD;
                  perinatal asphyxia;&#xD;
&#xD;
               -  ostomy caused by surgical treatment for a condition other than NEC or small&#xD;
                  intestine perforation; and&#xD;
&#xD;
               -  unable to initiate enteral feeding for more than 28 days since ostomy placement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>2 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qing Yang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>WFUHS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Science</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yang Q, Kock ND. Effects of dietary fish oil on intestinal adaptation in 20-day-old weanling rats after massive ileocecal resection. Pediatr Res. 2010 Sep;68(3):183-7. doi: 10.1203/PDR.0b013e3181eb2ee5.</citation>
    <PMID>20531250</PMID>
  </reference>
  <reference>
    <citation>Yang Q, Lan T, Chen Y, Dawson PA. Dietary fish oil increases fat absorption and fecal bile acid content without altering bile acid synthesis in 20-d-old weanling rats following massive ileocecal resection. Pediatr Res. 2012 Jul;72(1):38-42. doi: 10.1038/pr.2012.41. Epub 2012 Mar 23.</citation>
    <PMID>22447320</PMID>
  </reference>
  <results_reference>
    <citation>Yang Q, Welch CD, Ayers K, Turner C, Pranikoff T. Early enteral fat supplementation with microlipid(R) and fish oil in the treatment of two premature infants with short bowel. Neonatology. 2010;98(4):348-53. doi: 10.1159/000316067. Epub 2010 Oct 27.</citation>
    <PMID>20980771</PMID>
  </results_reference>
  <results_reference>
    <citation>Woods CW, Ayers K, Turner C, Pranikoff T and Qing Yang. A Novel Nutritional Approach to Prevent Parenteral Nutrition-Associated Cholestasis in Two Premature Infants with Short Bowel Syndrome. ICAN: Infant, Child, &amp; Adolescent Nutrition 2013 5: 32-36.</citation>
  </results_reference>
  <results_reference>
    <citation>Yang Q, Ayers K, Chen Y, Helderman J, Welch CD, O'Shea TM. Early enteral fat supplement and fish oil increases fat absorption in the premature infant with an enterostomy. J Pediatr. 2013 Aug;163(2):429-34. doi: 10.1016/j.jpeds.2013.01.056. Epub 2013 Feb 28.</citation>
    <PMID>23453547</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>August 29, 2018</results_first_submitted>
  <results_first_submitted_qc>November 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 4, 2018</results_first_posted>
  <last_update_submitted>November 7, 2018</last_update_submitted>
  <last_update_submitted_qc>November 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NEC, SBS, enterostomy, fish oil, Microlipid, Intralipid,</keyword>
  <keyword>enteral fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</mesh_term>
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Intestinal Perforation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Microlipid and Fish Oil Group</title>
          <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
        </group>
        <group group_id="P2">
          <title>Microlipid Group</title>
          <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Microlipid and Fish Oil Group</title>
          <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
        </group>
        <group group_id="B2">
          <title>Microlipid Group</title>
          <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>values represent the gestational age</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.3" spread="2.0"/>
                    <measurement group_id="B2" value="25.9" spread="2.0"/>
                    <measurement group_id="B3" value="26.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Serum Biomarkers of Inflammatory Cytokines</title>
        <description>Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
        <time_frame>2 years and 5 months</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Microlipid and Fish Oil Group</title>
            <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
          </group>
          <group group_id="O2">
            <title>Microlipid Group</title>
            <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
          </group>
        </group_list>
        <measure>
          <title>The Serum Biomarkers of Inflammatory Cytokines</title>
          <description>Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Average Enteral Calorie (Total Calorie) Intake Before Reanast</title>
        <description>To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
        <time_frame>2 years and 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Microlipid and Fish Oil Group</title>
            <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
          </group>
          <group group_id="O2">
            <title>Microlipid Group</title>
            <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
          </group>
        </group_list>
        <measure>
          <title>The Average Enteral Calorie (Total Calorie) Intake Before Reanast</title>
          <description>To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
          <units>kcal/kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.1" spread="23.6"/>
                    <measurement group_id="O2" value="56.7" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Average Weight Gain (g/Day) After Reanastomosis</title>
        <description>To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis</description>
        <time_frame>2 years and 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Microlipid and Fish Oil Group</title>
            <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
          </group>
          <group group_id="O2">
            <title>Microlipid Group</title>
            <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
          </group>
        </group_list>
        <measure>
          <title>The Average Weight Gain (g/Day) After Reanastomosis</title>
          <description>To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis</description>
          <units>g/d</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="8.5"/>
                    <measurement group_id="O2" value="20.9" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Serum Biomarkers of Oxidative Stress</title>
        <description>Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
        <time_frame>2 years and 5 months</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Microlipid and Fish Oil Group</title>
            <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
          </group>
          <group group_id="O2">
            <title>Microlipid Group</title>
            <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
          </group>
        </group_list>
        <measure>
          <title>The Serum Biomarkers of Oxidative Stress</title>
          <description>Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years and 5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Microlipid and Fish Oil Group</title>
          <description>This group will be given early enteral lipid supplementation with Microlipid and fish oil.&#xD;
Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.</description>
        </group>
        <group group_id="E2">
          <title>Microlipid Group</title>
          <description>This group will be given early enteral lipid supplementation only with Microlipid.&#xD;
Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Qing Yang</name_or_title>
      <organization>Wake Forest University Health Sciences</organization>
      <email>qyang@wakehealth.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01674478
org study id: IRB00021481
nct id: NCT01674478
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common
      devastating gastrointestinal diseases in premature infants. These infants often need surgical
      intervention to remove the dead bowel and create temporary enterostomies, resulting in short
      bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction
      to digest and absorb nutrients adequately.

      These infants are often nourished primarily with parental nutrition (PN) which can lead to
      many complications including PN-associated liver disease. However, with enteral feeding, the
      remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral
      fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty
      acids (LCPUFA) being the most beneficial in promoting bowel adaptation.

      Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.
      Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and
      increase weight gain in some SBS infants. WThe investigators will soon have completed a
      randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early
      Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with
      Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were
      able to decrease the use of IL; (b) premature infants in the treatment group who received
      ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and
      better weight gain (g/day) after reanastomosis than those who received routine care in
      control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in
      the treatment group than the control group although the difference was not statistically
      significant. Because the intervention consisted of both an increase in enteral fat intake as
      well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in
      the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat
      intake. Therefore, the investigators have designed a next randomized clinical trial to
      compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO
      will result in decreased systemic inflammation, as indicated by blood levels of
      inflammation-related proteins and indicators of oxidative stress.
In comparison to EMLFO trial, the EMLFO-2 study will modify the eligibility criteria to only
      enroll the infants who have birthweight equal to or less than 1250 g with a jejunostomy or
      ileostomy as the result of surgical treatment for small intestine perforation or NEC in order
      to increase the homogeneity of patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Serum Biomarkers of Inflammatory Cytokines
time frame: 2 years and 5 months
description: Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis
measure: The Serum Biomarkers of Oxidative Stress
time frame: 2 years and 5 months
description: Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis
measure: The Average Enteral Calorie (Total Calorie) Intake Before Reanast
time frame: 2 years and 5 months
description: To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis
measure: The Average Weight Gain (g/Day) After Reanastomosis
time frame: 2 years and 5 months
description: To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis
arm group label: Microlipid with fish oil group
arm group type: Experimental
description: This group will be given early enteral lipid supplementation with Microlipid and fish oil.
arm group label: Microlipid group
arm group type: Active Comparator
description: This group will be given early enteral lipid supplementation only with Microlipid.
intervention type: Dietary Supplement
intervention name: Microlipid with fish oil
description: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.
arm group label: Microlipid with fish oil group
intervention type: Dietary Supplement
intervention name: Microlipid
description: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
arm group label: Microlipid group
criteria: 
gender: All
minimum age: 1 Day
maximum age: 2 Months
healthy volunteers: No
last name: Qing Yang, MD, PhD
role: Principal Investigator
affiliation: WFUHS
facility: 
country: United States
citation: Yang Q, Kock ND. Effects of dietary fish oil on intestinal adaptation in 20-day-old weanling rats after massive ileocecal resection. Pediatr Res. 2010 Sep;68(3):183-7. doi: 10.1203/PDR.0b013e3181eb2ee5.
PMID: 20531250
citation: Yang Q, Lan T, Chen Y, Dawson PA. Dietary fish oil increases fat absorption and fecal bile acid content without altering bile acid synthesis in 20-d-old weanling rats following massive ileocecal resection. Pediatr Res. 2012 Jul;72(1):38-42. doi: 10.1038/pr.2012.41. Epub 2012 Mar 23.
PMID: 22447320
citation: Yang Q, Welch CD, Ayers K, Turner C, Pranikoff T. Early enteral fat supplementation with microlipid(R) and fish oil in the treatment of two premature infants with short bowel. Neonatology. 2010;98(4):348-53. doi: 10.1159/000316067. Epub 2010 Oct 27.
PMID: 20980771
citation: Woods CW, Ayers K, Turner C, Pranikoff T and Qing Yang. A Novel Nutritional Approach to Prevent Parenteral Nutrition-Associated Cholestasis in Two Premature Infants with Short Bowel Syndrome. ICAN: Infant, Child, & Adolescent Nutrition 2013 5: 32-36.
citation: Yang Q, Ayers K, Chen Y, Helderman J, Welch CD, O'Shea TM. Early enteral fat supplement and fish oil increases fat absorption in the premature infant with an enterostomy. J Pediatr. 2013 Aug;163(2):429-34. doi: 10.1016/j.jpeds.2013.01.056. Epub 2013 Feb 28.
PMID: 23453547
responsible party type: Sponsor
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing
mesh term: Short Bowel Syndrome
mesh term: Intestinal Perforation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 