<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/NCT01683162</url>
  </required_header>
  <id_info>
    <org_study_id>PNDLEIPI</org_study_id>
    <nct_id>NCT01683162</nct_id>
  </id_info>
  <brief_title>Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants</brief_title>
  <official_title>Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wei Cai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in&#xD;
      preterm infants, a showed efficacy and a good clinical and biological safety profile. The&#xD;
      objective of this study was to assess the effects of a new olive-oil based lipid emulsion&#xD;
      compared with the traditional lipid emulsions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a number of years, lipid emulsions have been used in the nutritional support of surgical&#xD;
      and critically ill patients, with the aim of supplying substrates to meet energy demands and&#xD;
      providing building blocks for wound healing and tissue repair. Two types of lipid emulsions&#xD;
      are currently used for adult as well as pediatric patients: one lipid emulsions prepared from&#xD;
      soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are&#xD;
      polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50%&#xD;
      medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared&#xD;
      from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion&#xD;
      (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations&#xD;
      with olive oil-based emulsion including in-vitro studies, animal studies, and infusion&#xD;
      studies in healthy subjects and in various patient groups. In-vitro and animal studies&#xD;
      demonstrate that the impairment of immune function, especially of T cell responses, that&#xD;
      occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and&#xD;
      adults have consistently shown that olive oil-based emulsion increases the oleic acid content&#xD;
      of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of&#xD;
      linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of&#xD;
      olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies&#xD;
      are required to test their beneficial effect from olive oil consumption in preterm infants.&#xD;
&#xD;
      The investigators designed a double-blind, randomized clinical trial to performed the effect&#xD;
      of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT&#xD;
      lipid emulsions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>lipometabolism</measure>
    <time_frame>Change from Baseline in fatty acid at 7 days and 14 days</time_frame>
    <description>fatty acid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxidative stress</measure>
    <time_frame>Change from Baseline in liver function at 7 days and 14 days</time_frame>
    <description>superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>clinical outcomes</measure>
    <time_frame>before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks</time_frame>
    <description>the growth of weight and head circumference, days on ventilator, length of hospitalization, morbidity of sepsis and NEC</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Preterm Infant</condition>
  <arm_group>
    <arm_group_label>Olive oil lipid emulsion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the olive oil lipid emulsion is ClinOleic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCT/LCT lipid emulsion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the MCT/LCT lipid emulsion is Lipofundin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LCT lipid emulsion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the LCT lipid emulsion is Intralipid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ClinOleic</intervention_name>
    <description>the lipid of all-in-one, 0.5-3.5g/kg.d</description>
    <arm_group_label>Olive oil lipid emulsion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipofundin</intervention_name>
    <description>the lipid of all-in-one, 0.5-3.5g/kg.d</description>
    <arm_group_label>MCT/LCT lipid emulsion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intralipid</intervention_name>
    <description>the lipid of all-in-one, 0.5-3.5g/kg.d</description>
    <arm_group_label>LCT lipid emulsion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants of both genders&#xD;
&#xD;
          -  Hospitalized&#xD;
&#xD;
          -  The parent of the infant agreed to participate by signing an informed consent form&#xD;
&#xD;
          -  Infants admitted hospital within 72 hours after birth(gestational age&lt;37 weeks)&#xD;
&#xD;
          -  Birth weight &lt;= 2000g&#xD;
&#xD;
          -  No PN support contraindications&#xD;
&#xD;
          -  Parenteral nutrition for 14 days or more&#xD;
&#xD;
          -  The parent of the infant is to sign an informed consent form prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving PN before screening&#xD;
&#xD;
          -  EN caloric&gt;10%&#xD;
&#xD;
          -  Obstruction jaundice&#xD;
&#xD;
          -  Suspected or identified biliary tract atresia&#xD;
&#xD;
          -  Neonatal hepatitis&#xD;
&#xD;
          -  Infants with liver markers &gt;2 times normal levels&#xD;
&#xD;
          -  Infants with renal markers &gt;2 times normal levels&#xD;
&#xD;
          -  Congenital metabolic situations&#xD;
&#xD;
          -  Identified as having major chromosomal disease&#xD;
&#xD;
          -  CMV, virus hepatitis and syphilis infection&#xD;
&#xD;
          -  Congenital or acquired immune deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying Wang, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying Wang, Phd</last_name>
    <phone>8613611884226</phone>
    <email>wangying_ssmu@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Cai, Phd</last_name>
    <email>caiw204@yahoo.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Wang, Phd</last_name>
      <phone>8613611884226</phone>
      <email>wangying_ssmu@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Wei Cai, Phd</last_name>
      <email>caiw204@yahoo.com.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Ying Wang, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qing-ya Tang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Li-na Lu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wei Cai, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Li Hong, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yi Feng</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 15, 2012</last_update_submitted>
  <last_update_submitted_qc>September 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Wei Cai</investigator_full_name>
    <investigator_title>vice-president</investigator_title>
  </responsible_party>
  <keyword>parenteral nutrition</keyword>
  <keyword>lipid emulsion</keyword>
  <keyword>olive oil</keyword>
  <keyword>liver function</keyword>
  <keyword>fatty acid</keyword>
  <keyword>clinical outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Soybean oil, phospholipid emulsion</mesh_term>
  </intervention_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/NCT01683162
org study id: PNDLEIPI
nct id: NCT01683162
lead sponsor: 
has dmc: Yes
Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in
      preterm infants, a showed efficacy and a good clinical and biological safety profile. The
      objective of this study was to assess the effects of a new olive-oil based lipid emulsion
      compared with the traditional lipid emulsions.
For a number of years, lipid emulsions have been used in the nutritional support of surgical
      and critically ill patients, with the aim of supplying substrates to meet energy demands and
      providing building blocks for wound healing and tissue repair. Two types of lipid emulsions
      are currently used for adult as well as pediatric patients: one lipid emulsions prepared from
      soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are
      polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50%
      medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared
      from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion
      (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations
      with olive oil-based emulsion including in-vitro studies, animal studies, and infusion
      studies in healthy subjects and in various patient groups. In-vitro and animal studies
      demonstrate that the impairment of immune function, especially of T cell responses, that
      occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and
      adults have consistently shown that olive oil-based emulsion increases the oleic acid content
      of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of
      linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of
      olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies
      are required to test their beneficial effect from olive oil consumption in preterm infants.

      The investigators designed a double-blind, randomized clinical trial to performed the effect
      of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT
      lipid emulsions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: lipometabolism
time frame: Change from Baseline in fatty acid at 7 days and 14 days
description: fatty acid
measure: oxidative stress
time frame: Change from Baseline in liver function at 7 days and 14 days
description: superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)
measure: clinical outcomes
time frame: before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks
description: the growth of weight and head circumference, days on ventilator, length of hospitalization, morbidity of sepsis and NEC
arm group label: Olive oil lipid emulsion
arm group type: Experimental
description: the olive oil lipid emulsion is ClinOleic
arm group label: MCT/LCT lipid emulsion
arm group type: Experimental
description: the MCT/LCT lipid emulsion is Lipofundin
arm group label: LCT lipid emulsion
arm group type: Experimental
description: the LCT lipid emulsion is Intralipid
intervention type: Drug
intervention name: ClinOleic
description: the lipid of all-in-one, 0.5-3.5g/kg.d
arm group label: Olive oil lipid emulsion
intervention type: Drug
intervention name: Lipofundin
description: the lipid of all-in-one, 0.5-3.5g/kg.d
arm group label: MCT/LCT lipid emulsion
intervention type: Drug
intervention name: Intralipid
description: the lipid of all-in-one, 0.5-3.5g/kg.d
arm group label: LCT lipid emulsion
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Year
healthy volunteers: No
last name: Ying Wang, phd
role: Principal Investigator
affiliation: Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China
last name: Ying Wang, Phd
phone: 8613611884226
email: wangying_ssmu@126.com
last name: Wei Cai, Phd
email: caiw204@yahoo.com.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Wei Cai
investigator title: vice-president
mesh term: Premature Birth
mesh term: Soybean oil, phospholipid emulsion