<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/NCT03785990</url>
  </required_header>
  <id_info>
    <org_study_id>NEO-Adipose tissue</org_study_id>
    <nct_id>NCT03785990</nct_id>
  </id_info>
  <brief_title>Fatty Acid Composition of Subcutaneous Adipose Tissue in Infants: A Prospective and Observational Study</brief_title>
  <official_title>Untersuchung Intraoperativ Entnommener Subkutaner Fettgewebeproben Früh- Und Reifgeborener Auf Die Fettsäure-Zusammensetzung Der Triglyceride Und Der Phospholipide Mit Speziellem Fokus Auf Die Mehrfach ungesättigten Fettsäuren Docosahexaensäure Und Arachidonsäure Wissenschaftliche Untersuchung Bei Minderjährigen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an&#xD;
      clinical indicated operation is studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Collection of:&#xD;
&#xD;
        -  subcutaneous adipose tissue of term infants and preterms after birth and at term during&#xD;
           a clinically indicated operation.&#xD;
&#xD;
        -  blood before the operation.&#xD;
&#xD;
      Measurement of the fatty acid composition (especially arachidonic acid and docosahexaenoic&#xD;
      acid) in subcutaneous adipose tissue and blood.&#xD;
&#xD;
      Aim is to compare the composition of the fatty acids in blood and adipose tissue of preterms&#xD;
      at term and term infants. To calculate the fatty acid value in each infant the proportion of&#xD;
      adipose tissue is determined with PEAPOD before discharge from hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</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>Fatty acid composition of the subcutaneous adipose tissue and plasma</measure>
    <time_frame>at the time of the operation</time_frame>
    <description>Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of infants after birth (within 14 days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems</measure>
    <time_frame>time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)</time_frame>
    <description>Change of fatty acid composition of the subcutaneous tissue and plasma from first to second operation in preterms with abdominal operations, enterostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term</measure>
    <time_frame>time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)</time_frame>
    <description>Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of preterms at term with enterostomy.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Prematurity</condition>
  <condition>Subcutaneous Adipose Tissue</condition>
  <arm_group>
    <arm_group_label>preterms with enterostomy</arm_group_label>
    <description>GA 23±0/7 - 31±6/7 with clinically indicated operations because of NEC (necrotising enterocolitis) or FIP (focal intestinal perforation). Operation after birth (within 14 days) and at term (enterostomy closure) Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preterms without enterostomy</arm_group_label>
    <description>GA 23±0/7 bis 31±6/7 with a clinically indicated operation (e.g. herniotomy) at term, without any abdominal problems.&#xD;
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>term infants</arm_group_label>
    <description>GA ≥34±0/7 with a clinically indicated operation directly after birth (within 14 days) (e.g. gastroschisis).&#xD;
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>adipose tissue</intervention_name>
    <description>taking a sample of the adipose tissue during operation</description>
    <arm_group_label>preterms with enterostomy</arm_group_label>
    <arm_group_label>preterms without enterostomy</arm_group_label>
    <arm_group_label>term infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood</intervention_name>
    <description>taking a blood sample when a peripheral venous catheter is inserted before operation</description>
    <arm_group_label>preterms with enterostomy</arm_group_label>
    <arm_group_label>preterms without enterostomy</arm_group_label>
    <arm_group_label>term infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PEAPOD</intervention_name>
    <description>Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)</description>
    <arm_group_label>preterms with enterostomy</arm_group_label>
    <arm_group_label>preterms without enterostomy</arm_group_label>
    <arm_group_label>term infants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        term and preterm neonates&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meeting criteria of the 3 cohorts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metabolic diseases of the infant&#xD;
&#xD;
          -  genetic diseases&#xD;
&#xD;
          -  missing agreement for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Axel Franz</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katrin Böckmann</last_name>
    <phone>+49707129</phone>
    <phone_ext>82621</phone_ext>
    <email>katrin.boeckmann@med.uni-tuebingen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Axel Franz, MD</last_name>
    <phone>+49707129</phone>
    <phone_ext>83791</phone_ext>
    <email>axel.franz@med.uni-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Axel R Franz, MD</last_name>
      <phone>+49707129-0</phone>
      <phone_ext>82211</phone_ext>
      <email>axel.franz@med.uni-tuebingen.de</email>
    </contact>
    <investigator>
      <last_name>Axel R Franz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>May 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>preterm</keyword>
  <keyword>fatty acid</keyword>
  <keyword>docosahexaenoic acid</keyword>
  <keyword>arachidonic acid</keyword>
  <keyword>infant</keyword>
  <keyword>adipose tissue</keyword>
  <keyword>subcutaneous adipose tissue</keyword>
  <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/NCT03785990
org study id: NEO-Adipose tissue
nct id: NCT03785990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an
      clinical indicated operation is studied.
Collection of:

        -  subcutaneous adipose tissue of term infants and preterms after birth and at term during
           a clinically indicated operation.

        -  blood before the operation.

      Measurement of the fatty acid composition (especially arachidonic acid and docosahexaenoic
      acid) in subcutaneous adipose tissue and blood.

      Aim is to compare the composition of the fatty acids in blood and adipose tissue of preterms
      at term and term infants. To calculate the fatty acid value in each infant the proportion of
      adipose tissue is determined with PEAPOD before discharge from hospital.
observational model: Cohort
time perspective: Prospective
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma
time frame: at the time of the operation
description: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of infants after birth (within 14 days).
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems
time frame: time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)
description: Change of fatty acid composition of the subcutaneous tissue and plasma from first to second operation in preterms with abdominal operations, enterostomy
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term
time frame: time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)
description: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of preterms at term with enterostomy.
arm group label: preterms with enterostomy
description: GA 23±0/7 - 31±6/7 with clinically indicated operations because of NEC (necrotising enterocolitis) or FIP (focal intestinal perforation). Operation after birth (within 14 days) and at term (enterostomy closure) Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)
arm group label: preterms without enterostomy
description: GA 23±0/7 bis 31±6/7 with a clinically indicated operation (e.g. herniotomy) at term, without any abdominal problems.
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)
arm group label: term infants
description: GA ≥34±0/7 with a clinically indicated operation directly after birth (within 14 days) (e.g. gastroschisis).
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD)
intervention type: Other
intervention name: adipose tissue
description: taking a sample of the adipose tissue during operation
arm group label: preterms with enterostomy
arm group label: preterms without enterostomy
arm group label: term infants
intervention type: Other
intervention name: blood
description: taking a blood sample when a peripheral venous catheter is inserted before operation
arm group label: preterms with enterostomy
arm group label: preterms without enterostomy
arm group label: term infants
intervention type: Diagnostic Test
intervention name: PEAPOD
description: Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)
arm group label: preterms with enterostomy
arm group label: preterms without enterostomy
arm group label: term infants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Axel Franz
role: Principal Investigator
affiliation: University Hospital Tuebingen
last name: Katrin Böckmann
phone: +49707129
phone ext: 82621
email: katrin.boeckmann@med.uni-tuebingen.de
last name: Axel Franz, MD
phone: +49707129
phone ext: 83791
email: axel.franz@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No