<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/NCT01731613</url>
  </required_header>
  <id_info>
    <org_study_id>8648</org_study_id>
    <nct_id>NCT01731613</nct_id>
  </id_info>
  <brief_title>Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants</brief_title>
  <official_title>Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mead Johnson Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will compare how the individualized and fortified human milk feeding will&#xD;
      help a premature infant grow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 60 premature infants who will be randomized to receive either a standard&#xD;
      fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable&#xD;
      fortification regimen encompasses increasing / decreasing the amount of fortifier and adding&#xD;
      supplemental protein guided by periodic determinations of the protein concentration in human&#xD;
      milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral&#xD;
      feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition&#xD;
      and NICU stays will be measured and compared between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to reach 100kcal/kg/d of enteral nutrition</measure>
    <time_frame>participants will be followed until discharge, an expected average of 2 weeks</time_frame>
    <description>Days to reach 100kcal/kg/d of enteral nutrition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The weight gain velocity during hospitalization</measure>
    <time_frame>participants will be followed until discharge, an expected average of 2 weeks</time_frame>
    <description>The weight gain velocity(g/kg/d)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The protein and energy ratio of enteral nutrition each week after enrollment</measure>
    <time_frame>participants will be followed until discharge, an expected average of 2 weeks</time_frame>
    <description>The protein and energy ratio(g/100kcal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach 2000g of body weight</measure>
    <time_frame>participants will be followed until discharge, an expected average of 2 weeks</time_frame>
    <description>Days to reach 2000g of body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic indicators after enrollment, including BUN,prealbumin, albumin</measure>
    <time_frame>participants will be followed until discharge, an expected average of 2 weeks</time_frame>
    <description>BUN(mmol/L), prealbumin(mg/L), albumin(g/L)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Infant, Premature, Diseases</condition>
  <arm_group>
    <arm_group_label>Standard Fortification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjustable fortification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>human milk fortifier</intervention_name>
    <description>Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen</description>
    <arm_group_label>Adjustable fortification</arm_group_label>
    <arm_group_label>Standard Fortification</arm_group_label>
    <other_name>HMF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than 34 weeks gestational age at birth&#xD;
&#xD;
          -  Birth weight within 800-1800 grams&#xD;
&#xD;
          -  Exclusively or mostly breastfed (greater than 80% if the feeding volume)&#xD;
&#xD;
          -  Tolerated enteral feedings of 60 ml/kg/d&#xD;
&#xD;
          -  Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital&#xD;
             discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Small for gestational age&#xD;
&#xD;
          -  Infants currently receiving ventilation therapy&#xD;
&#xD;
          -  Major congenital malformations&#xD;
&#xD;
          -  Suspected or documented systemic or congenital infections&#xD;
&#xD;
          -  Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or&#xD;
             other systemic diseases that may impact growth&#xD;
&#xD;
          -  Severe intraventricular hemorrhage (greater than grade II) or periventricular&#xD;
             leukomalacia&#xD;
&#xD;
          -  Suspected or documented maternal substance abuse&#xD;
&#xD;
          -  Infants currently receiving glucocorticoids or infants who have received&#xD;
             glucocorticoids within the past 28 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Days</minimum_age>
    <maximum_age>40 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danhua Wang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 25, 2017</last_update_submitted>
  <last_update_submitted_qc>November 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Danhua Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infant, Premature, Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 9, 2017</submitted>
    <returned>August 24, 2018</returned>
  </pending_results>
  <!-- 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/NCT01731613
org study id: 8648
nct id: NCT01731613
lead sponsor: 
collaborator: 
has dmc: No
This clinical trial will compare how the individualized and fortified human milk feeding will
      help a premature infant grow.
A total of 60 premature infants who will be randomized to receive either a standard
      fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable
      fortification regimen encompasses increasing / decreasing the amount of fortifier and adding
      supplemental protein guided by periodic determinations of the protein concentration in human
      milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral
      feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition
      and NICU stays will be measured and compared between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Time to reach 100kcal/kg/d of enteral nutrition
time frame: participants will be followed until discharge, an expected average of 2 weeks
description: Days to reach 100kcal/kg/d of enteral nutrition
measure: The weight gain velocity during hospitalization
time frame: participants will be followed until discharge, an expected average of 2 weeks
description: The weight gain velocity(g/kg/d)
measure: The protein and energy ratio of enteral nutrition each week after enrollment
time frame: participants will be followed until discharge, an expected average of 2 weeks
description: The protein and energy ratio(g/100kcal)
measure: Time to reach 2000g of body weight
time frame: participants will be followed until discharge, an expected average of 2 weeks
description: Days to reach 2000g of body weight
measure: metabolic indicators after enrollment, including BUN,prealbumin, albumin
time frame: participants will be followed until discharge, an expected average of 2 weeks
description: BUN(mmol/L), prealbumin(mg/L), albumin(g/L)
arm group label: Standard Fortification
arm group type: Active Comparator
description: receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study
arm group label: Adjustable fortification
arm group type: Experimental
description: encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)
intervention type: Dietary Supplement
intervention name: human milk fortifier
description: Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
arm group label: Adjustable fortification
arm group label: Standard Fortification
other name: HMF
criteria: 
gender: All
minimum age: 10 Days
maximum age: 40 Days
healthy volunteers: No
last name: Danhua Wang, Professor
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Danhua Wang
investigator title: Professor
mesh term: Infant, Premature, Diseases
sharing ipd: No
submitted: December 9, 2017
returned: August 24, 2018