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

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

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Infant
• Intervention / Treatment: Drug: SMOFlipid; Drug: Lipofundin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fatty acids spectrum	cholic acid, deoxycholic acid,chenodeoxycholic acid,ursodeoxycholic acid and lithocholic acid in mol%,et al.	change from baseline in fatty acids spectrum at 7 days and 14 days

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Ying Wang, Phd, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: oxidative stress; lipid emulsion; parenteral nutrition; SMOF; PNALD
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; SMOFlipid
• Other Study ID Numbers: PNALD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No