search
Back to results

Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants

Primary Purpose

Preterm Infant

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
SMOFlipid
Lipofundin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth
  • No contraindications to parenteral nutrition
  • Expected PN support for 14 days or more
  • Parents or guardians agree

Exclusion Criteria:

  • Parenteral nutrition support was provided prior to enrollment
  • EN calorie for 10% or more
  • Congenital intestinal structural/functional abnormalities
  • Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract
  • Congenital or acquired immunodeficiency
  • Complex congenital heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SMOF lipid emulsion

    MCT/LCT lipid emulsion

    Arm Description

    the SMOF lipid emulsion is SMOFlipid.

    the MCT/LCT lipid emulsion is Lipofundin.

    Outcomes

    Primary Outcome Measures

    Change of liver function indexes
    liver enzyme in u/L
    Change of bilirubin indexes
    bilirubin in μmol/L

    Secondary Outcome Measures

    Change of superoxidase dismutase
    superoxidase dismutase in u/L
    Change of malondialdehyde
    malondialdehyde in nmol/ml
    Change of inflammatory factors
    IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-α in pg/ml

    Full Information

    First Posted
    January 6, 2020
    Last Updated
    February 19, 2020
    Sponsor
    Shanghai Jiao Tong University School of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04277923
    Brief Title
    Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants
    Official Title
    Effects of Medium and Long Chain Fat Emulsions and SMOF Fat Emulsions on PNALD and Oxidative Stress in Premature Infants: a Randomized, Double-blind Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.
    Detailed Description
    For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution. Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress. Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Infant
    Keywords
    parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SMOF lipid emulsion
    Arm Type
    Experimental
    Arm Description
    the SMOF lipid emulsion is SMOFlipid.
    Arm Title
    MCT/LCT lipid emulsion
    Arm Type
    Experimental
    Arm Description
    the MCT/LCT lipid emulsion is Lipofundin.
    Intervention Type
    Drug
    Intervention Name(s)
    SMOFlipid
    Intervention Description
    the lipid of all-in-one is less than 4g/kg.d
    Intervention Type
    Drug
    Intervention Name(s)
    Lipofundin
    Intervention Description
    the lipid of all-in-one is less than 4g/kg.d
    Primary Outcome Measure Information:
    Title
    Change of liver function indexes
    Description
    liver enzyme in u/L
    Time Frame
    change from baseline in liver function indexes at 7 days and 14 days
    Title
    Change of bilirubin indexes
    Description
    bilirubin in μmol/L
    Time Frame
    change from baseline in bilirubin indexes at 7 days and 14 days
    Secondary Outcome Measure Information:
    Title
    Change of superoxidase dismutase
    Description
    superoxidase dismutase in u/L
    Time Frame
    change from baseline in superoxidase dismutase at 7 days and 14 days
    Title
    Change of malondialdehyde
    Description
    malondialdehyde in nmol/ml
    Time Frame
    change from baseline in malondialdehyde at 7 days and 14 days
    Title
    Change of inflammatory factors
    Description
    IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-α in pg/ml
    Time Frame
    change from baseline in fatty acid at 7 days and 14 days
    Other Pre-specified Outcome Measures:
    Title
    Change of fatty acids spectrum
    Description
    cholic acid, deoxycholic acid,chenodeoxycholic acid,ursodeoxycholic acid and lithocholic acid in mol%,et al.
    Time Frame
    change from baseline in fatty acids spectrum at 7 days and 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth No contraindications to parenteral nutrition Expected PN support for 14 days or more Parents or guardians agree Exclusion Criteria: Parenteral nutrition support was provided prior to enrollment EN calorie for 10% or more Congenital intestinal structural/functional abnormalities Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract Congenital or acquired immunodeficiency Complex congenital heart disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ying Wang, Phd
    Phone
    8613611884226
    Email
    wangying_ssmu@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ying Wang, Phd
    Organizational Affiliation
    Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants

    We'll reach out to this number within 24 hrs