<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/NCT02995577</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-16-0968</org_study_id>
    <nct_id>NCT02995577</nct_id>
  </id_info>
  <brief_title>Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation</brief_title>
  <official_title>Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigates serum and stool biomarkers as predictors for&#xD;
      post-operative feeding intolerance in infant patients with complex congenital heart defects&#xD;
      who undergo single ventricle staged palliation surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of most abundant serum protein as determined by ELISA</measure>
    <time_frame>baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery</time_frame>
    <description>We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of second most abundant serum protein as determined by ELISA</measure>
    <time_frame>baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA</measure>
    <time_frame>baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of stool biomarker calprotectin as determined by ELISA</measure>
    <time_frame>baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Single Ventricle Physiology</condition>
  <arm_group>
    <arm_group_label>Feeding tolerant</arm_group_label>
    <description>Patients that are able to reach 80-100% of full enteral feeds (whether fed by mouth or through a nasogastric tube) 7 days after the initiation of feeds. Patients will be excluded from this group if they are ever diagnosed with NEC at any time during this hospitalization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feeding intolerant</arm_group_label>
    <description>Patients with GI symptoms (vomiting, abdominal distention, diarrhea, hematemesis, and/or hematochezia) that persist for 48 hours or longer while needing to be NPO, this patient is retrospectively categorized into the feeding intolerance group. Patients with feeding intolerance may also include infants that are made NPO, placed on bowel rest, and are started on antibiotics to rule out NEC, but are never diagnosed with NEC. Exclusion criteria include patients that are continued on antibiotics for greater than 48 hours due to diagnosed bacterial sepsis or diagnosed NEC, and those that have a positive blood, urine, or sputum culture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Necrotizing enterocolitis</arm_group_label>
    <description>Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feeding tolerant</intervention_name>
    <arm_group_label>Feeding tolerant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feeding intolerant</intervention_name>
    <arm_group_label>Feeding intolerant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Necrotizing enterocolitis</intervention_name>
    <arm_group_label>Necrotizing enterocolitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be infants with complex congenital cyanotic heart disease&#xD;
        requiring single ventricle staged palliation surgery at Children's Memorial Hermann&#xD;
        Hospital (CMHH) at the Texas Medical Center. This will include neonates undergoing single&#xD;
        ventricle staged palliation in the form of (a) Norwood-type procedure, (b)&#xD;
        systemic-to-pulmonary artery shunt procedure, or (c) pulmonary artery banding.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full term gestational period (37 weeks gestation or greater)&#xD;
&#xD;
          -  minimum of 2.5kg or greater body weight&#xD;
&#xD;
          -  diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease&#xD;
             requiring staged palliation surgery in the form of Norwood-type procedure,&#xD;
             systemic-to-pulmonary artery shunt, or pulmonary artery banding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have diseases affecting other organs,&#xD;
&#xD;
          -  have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE&#xD;
             syndrome, or VACTERL association.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Supriya Nair, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Supriya Nair, MD</last_name>
    <phone>832-582-0683</phone>
    <email>Supriya.Nair@uth.tmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>J. Marc Rhoads, MD</last_name>
    <phone>(713) 500-5663</phone>
    <email>J.Marc.Rhoads@uth.tmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Supriya Nair, MD</last_name>
      <phone>832-582-0683</phone>
      <email>Supriya.Nair@uth.tmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Supriya Nair</investigator_full_name>
    <investigator_title>Pediatric GI Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Univentricular Heart</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/NCT02995577
org study id: HSC-MS-16-0968
nct id: NCT02995577
lead sponsor: 
The purpose of this study is to investigates serum and stool biomarkers as predictors for
      post-operative feeding intolerance in infant patients with complex congenital heart defects
      who undergo single ventricle staged palliation surgery.
observational model: Case-Control
time perspective: Prospective
measure: Level of most abundant serum protein as determined by ELISA
time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
description: We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.
measure: Level of second most abundant serum protein as determined by ELISA
time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
measure: Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA
time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
measure: Level of stool biomarker calprotectin as determined by ELISA
time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
arm group label: Feeding tolerant
description: Patients that are able to reach 80-100% of full enteral feeds (whether fed by mouth or through a nasogastric tube) 7 days after the initiation of feeds. Patients will be excluded from this group if they are ever diagnosed with NEC at any time during this hospitalization.
arm group label: Feeding intolerant
description: Patients with GI symptoms (vomiting, abdominal distention, diarrhea, hematemesis, and/or hematochezia) that persist for 48 hours or longer while needing to be NPO, this patient is retrospectively categorized into the feeding intolerance group. Patients with feeding intolerance may also include infants that are made NPO, placed on bowel rest, and are started on antibiotics to rule out NEC, but are never diagnosed with NEC. Exclusion criteria include patients that are continued on antibiotics for greater than 48 hours due to diagnosed bacterial sepsis or diagnosed NEC, and those that have a positive blood, urine, or sputum culture.
arm group label: Necrotizing enterocolitis
description: Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC.
intervention type: Other
intervention name: Feeding tolerant
arm group label: Feeding tolerant
intervention type: Other
intervention name: Feeding intolerant
arm group label: Feeding intolerant
intervention type: Other
intervention name: Necrotizing enterocolitis
arm group label: Necrotizing enterocolitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 3 Years
healthy volunteers: No
last name: Supriya Nair, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Supriya Nair, MD
phone: 832-582-0683
email: Supriya.Nair@uth.tmc.edu
last name: J. Marc Rhoads, MD
phone: (713) 500-5663
email: J.Marc.Rhoads@uth.tmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Supriya Nair
investigator title: Pediatric GI Fellow
mesh term: Heart Defects, Congenital
mesh term: Univentricular Heart