<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/NCT03013374</url>
  </required_header>
  <id_info>
    <org_study_id>Protein balance and FFM</org_study_id>
    <nct_id>NCT03013374</nct_id>
  </id_info>
  <brief_title>Protein Balance and Body Composition in Preterm Infants</brief_title>
  <official_title>Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The adequacy of the quality of protein supply could influence the rate and the relative&#xD;
      composition of weight gain in very low birth weight preterm infants.&#xD;
&#xD;
      Aim of the study is to investigate protein balance according to feeding regimen and the&#xD;
      association between human milk feeding and fat free mass content at term corrected age in a&#xD;
      cohort of very low birth weight infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nutritional management of preterm infants aims to approximate tissue growth and body&#xD;
      composition of a foetus of same postconceptional age. The adequacy of the quality of protein&#xD;
      supply could influence the rate and the relative composition of weight gain.&#xD;
&#xD;
      Aim of the study is to investigate protein balance according to feeding regimen and the&#xD;
      association between exclusive human milk feeding and fat free mass content at term corrected&#xD;
      age in a cohort of very low birth weight infants.&#xD;
&#xD;
      A prospective observational study. Infants are included according to inclusion criteria.&#xD;
      Enrollment is performed at hospital discharge. Infants are divided into two groups&#xD;
      (exclusively human milk or exclusively formula) according to own mother's milk availability.&#xD;
      At enrollment macronutrients' intakes and protein balance are determined. Anthropometric&#xD;
      measurements and body composition are also assessed. Nutritional composition of human milk is&#xD;
      calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is&#xD;
      determined according to nitrogen balance standard method. Body composition is assessed by an&#xD;
      air-displacement plethysmography system system (PEA POD Infant Body Composition System,&#xD;
      COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition&#xD;
      assessments are repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</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>Protein balance</measure>
    <time_frame>at hospital discharge (that is 35-36 post conceptional weeks)</time_frame>
    <description>Protein balance will be determined according to nitrogen balance standard method and defined as the difference between daily nitrogen intake and daily urinary nitrogen excretion. Nitrogen intake will be measured from the amount of total protein intake (i.e. grams of nitrogen intake=grams of protein intake/6.25).&#xD;
Urinary urea nitrogen excretion will be considered representative of total nitrogen loss. Urinary urea will be calculated from urine specimens collected by cotton balls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat free mass content</measure>
    <time_frame>Term corrected age (that is 40 post conceptional weeks)</time_frame>
    <description>Body composition will be assessed by an air-displacement plethysmography system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). The PEA POD assesses fat mass and fat-free mass by direct measurements of body mass and volume and the application of a classic densitometric model.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>PreTerm Birth</condition>
  <condition>Human Milk</condition>
  <arm_group>
    <arm_group_label>Human milk fed infants</arm_group_label>
    <description>Infants fed fortified human milk at enrollment&#xD;
Any intervention is performed. Groups distinction is made according to own mother's milk availability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preterm formula</arm_group_label>
    <description>Infants fed preterm formula milk at enrollment.&#xD;
Any intervention is performed. Groups distinction is made according to own mother's milk availability.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infants are enrolled at time of hospital discharge. Infants with gestational age ≤32 weeks,&#xD;
        birth weight &lt; 1500 grams and ≥10th percentile according to Fenton's growth chart, having&#xD;
        stable clinical conditions and feeding by mouth with either exclusively human milk or&#xD;
        formula at discharge were included. Exclusion criteria were the following: infants affected&#xD;
        by either congenital or chromosomal abnormalities or conditions that could interfere with&#xD;
        growth, such as chronic lung disease (as defined based on the classification of Jobe and&#xD;
        Bancalari), neurological disorders, metabolic, cardiac disease and abdominal surgery, renal&#xD;
        failure and/or sepsis (defined as a positive blood culture).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gestational age ≤32 weeks&#xD;
&#xD;
          -  birth weight &lt; 1500 grams&#xD;
&#xD;
          -  birth weight ≥10th percentile according to Fenton's growth chart&#xD;
&#xD;
          -  stable clinical conditions at discharge&#xD;
&#xD;
          -  feeding by mouth with either exclusively human milk or formula at discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital or chromosomal abnormalities&#xD;
&#xD;
          -  conditions that could interfere with growth such as chronic lung disease, neurological&#xD;
             disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or&#xD;
             sepsis (defined as a positive blood culture).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Morlacchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Morlacchi, MD</last_name>
    <phone>+39 0255032483</phone>
    <email>laura.morlacchi@mangiagalli.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paola Roggero, MD</last_name>
    <phone>+39 0255032483</phone>
    <email>paola.roggero@unimi.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Morlacchi, MD</last_name>
      <phone>+39 0255032483</phone>
      <email>laura.morlacchi@mangiagalli.it</email>
    </contact>
    <investigator>
      <last_name>Laura Morlacchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paola Roggero, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>protein accretion</keyword>
  <keyword>body composition</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>Undecided</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/NCT03013374
org study id: Protein balance and FFM
nct id: NCT03013374
lead sponsor: 
has dmc: No
The adequacy of the quality of protein supply could influence the rate and the relative
      composition of weight gain in very low birth weight preterm infants.

      Aim of the study is to investigate protein balance according to feeding regimen and the
      association between human milk feeding and fat free mass content at term corrected age in a
      cohort of very low birth weight infants.
Nutritional management of preterm infants aims to approximate tissue growth and body
      composition of a foetus of same postconceptional age. The adequacy of the quality of protein
      supply could influence the rate and the relative composition of weight gain.

      Aim of the study is to investigate protein balance according to feeding regimen and the
      association between exclusive human milk feeding and fat free mass content at term corrected
      age in a cohort of very low birth weight infants.

      A prospective observational study. Infants are included according to inclusion criteria.
      Enrollment is performed at hospital discharge. Infants are divided into two groups
      (exclusively human milk or exclusively formula) according to own mother's milk availability.
      At enrollment macronutrients' intakes and protein balance are determined. Anthropometric
      measurements and body composition are also assessed. Nutritional composition of human milk is
      calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is
      determined according to nitrogen balance standard method. Body composition is assessed by an
      air-displacement plethysmography system system (PEA POD Infant Body Composition System,
      COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition
      assessments are repeated.
observational model: Cohort
time perspective: Prospective
measure: Protein balance
time frame: at hospital discharge (that is 35-36 post conceptional weeks)
description: Protein balance will be determined according to nitrogen balance standard method and defined as the difference between daily nitrogen intake and daily urinary nitrogen excretion. Nitrogen intake will be measured from the amount of total protein intake (i.e. grams of nitrogen intake=grams of protein intake/6.25).
Urinary urea nitrogen excretion will be considered representative of total nitrogen loss. Urinary urea will be calculated from urine specimens collected by cotton balls.
measure: Fat free mass content
time frame: Term corrected age (that is 40 post conceptional weeks)
description: Body composition will be assessed by an air-displacement plethysmography system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). The PEA POD assesses fat mass and fat-free mass by direct measurements of body mass and volume and the application of a classic densitometric model.
arm group label: Human milk fed infants
description: Infants fed fortified human milk at enrollment
Any intervention is performed. Groups distinction is made according to own mother's milk availability.
arm group label: Preterm formula
description: Infants fed preterm formula milk at enrollment.
Any intervention is performed. Groups distinction is made according to own mother's milk availability.
Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 32 Weeks
healthy volunteers: No
last name: Laura Morlacchi, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
last name: Laura Morlacchi, MD
phone: +39 0255032483
email: laura.morlacchi@mangiagalli.it
last name: Paola Roggero, MD
phone: +39 0255032483
email: paola.roggero@unimi.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: Undecided