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
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
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
NCT ID
NCT04277923
First Posted
January 6, 2020
Last Updated
February 19, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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
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