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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Preterm Infant

Intervention / Treatment
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* Drug: SMOFlipid
* Drug: Lipofundin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMOF lipid emulsion<br>the SMOF lipid emulsion is SMOFlipid. | Drug: SMOFlipid<br>* the lipid of all-in-one is less than 4g/kg.d<br>|
| Experimental: MCT/LCT lipid emulsion<br>the MCT/LCT lipid emulsion is Lipofundin. | Drug: Lipofundin<br>* the lipid of all-in-one is less than 4g/kg.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of liver function indexes | liver enzyme in u/L | change from baseline in liver function indexes at 7 days and 14 days | 
| Change of bilirubin indexes | bilirubin in μmol/L | change from baseline in bilirubin indexes at 7 days and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of superoxidase dismutase | superoxidase dismutase in u/L | change from baseline in superoxidase dismutase at 7 days and 14 days | 
| Change of malondialdehyde | malondialdehyde in nmol/ml | change from baseline in malondialdehyde at 7 days and 14 days | 
| Change of inflammatory factors | IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-α in pg/ml | change from baseline in fatty acid at 7 days and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress