<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/NCT03238768</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000063</org_study_id>
    <nct_id>NCT03238768</nct_id>
  </id_info>
  <brief_title>Enhanced Nutrition for Preterm Infants</brief_title>
  <official_title>Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</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 overall objective of the proposal is to demonstrate the feasibility of providing&#xD;
      increased calories and protein in the first week of life to very low birth weight (VLBW)&#xD;
      preterm infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infants will be randomized to receive either standard parenteral nutrition via the neonatal&#xD;
      intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol&#xD;
      during their first week of life through higher initial macronutrient provision and faster&#xD;
      advancement of macronutrient provision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>
    <intervention_model_description>Infants will be randomized to receive either standard parenteral nutrition via the NICU protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life.</measure>
    <time_frame>1 week</time_frame>
    <description>We will calculate the actual amount of protein, kcals, lipids etc received in both groups at the end of the first week to determine if we were able to deliver increased amounts of nutrition to the enhanced protocol group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Enhanced Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomized to the study protocol will start on higher initial amounts of calories, proteins and fats. They will also undergo faster increases of these nutrients during their first week of life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants randomized to the standard nutrition protocol will start on standard amounts of calories, proteins and fats per the usual NICU routine. They will also undergo standard increases of these nutrients during their first week of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Intravenous Nutrition</intervention_name>
    <description>Increased macronutrients for first 7 days</description>
    <arm_group_label>Enhanced Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Intravenous Nutrition</intervention_name>
    <description>Standard macronutrients for first 7 days</description>
    <arm_group_label>Standard Nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  VLBW (birth weight &lt;1500grams) preterm (gestational age (GA) at birth &lt; 32 weeks)&#xD;
             infants admitted to the University of Minnesota Masonic Children's Hospital NICU, for&#xD;
             which written informed consent can be secured from a parent within 12 hours of birth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants who are diagnosed prenatally with a clinical condition (other than&#xD;
             prematurity) that is known to affect growth rate, adiposity, or neurocognitive&#xD;
             development, who experienced severe birth asphyxia, who are enrolled in another study&#xD;
             affecting nutritional management, or who are likely to be transferred out of the NICU&#xD;
             will be excluded from participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>30 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara E Ramel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota Masonic Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota Masonic Children's Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Body Composition</keyword>
  <keyword>Preterm</keyword>
  <keyword>Neonate</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03238768/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03238768/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03238768
org study id: STUDY00000063
nct id: NCT03238768
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall objective of the proposal is to demonstrate the feasibility of providing
      increased calories and protein in the first week of life to very low birth weight (VLBW)
      preterm infants.
Infants will be randomized to receive either standard parenteral nutrition via the neonatal
      intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol
      during their first week of life through higher initial macronutrient provision and faster
      advancement of macronutrient provision.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Infants will be randomized to receive either standard parenteral nutrition via the NICU protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
masking description: Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
measure: The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life.
time frame: 1 week
description: We will calculate the actual amount of protein, kcals, lipids etc received in both groups at the end of the first week to determine if we were able to deliver increased amounts of nutrition to the enhanced protocol group
arm group label: Enhanced Nutrition
arm group type: Experimental
description: Infants randomized to the study protocol will start on higher initial amounts of calories, proteins and fats. They will also undergo faster increases of these nutrients during their first week of life.
arm group label: Standard Nutrition
arm group type: Active Comparator
description: Infants randomized to the standard nutrition protocol will start on standard amounts of calories, proteins and fats per the usual NICU routine. They will also undergo standard increases of these nutrients during their first week of life.
intervention type: Other
intervention name: Enhanced Intravenous Nutrition
description: Increased macronutrients for first 7 days
arm group label: Enhanced Nutrition
intervention type: Other
intervention name: Standard Intravenous Nutrition
description: Standard macronutrients for first 7 days
arm group label: Standard Nutrition
criteria: 
gender: All
minimum age: N/A
maximum age: 30 Weeks
healthy volunteers: No
last name: Sara E Ramel, MD
role: Principal Investigator
affiliation: University of Minnesota Masonic Children's Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No
provided document: 
provided document: 