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

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04277923
• Collaborator: (none)
• Enrollment: 66
• Arms: 2
• Anticipated Duration (Months): 18

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Infant	Drug: SMOFlipid; Drug: Lipofundin	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of liver function indexes [change from baseline in liver function indexes at 7 days and 14 days]

   liver enzyme in u/L

2. Change of bilirubin indexes [change from baseline in bilirubin indexes at 7 days and 14 days]

   bilirubin in μmol/L

Secondary Outcome Measures

1. Change of superoxidase dismutase [change from baseline in superoxidase dismutase at 7 days and 14 days]

   superoxidase dismutase in u/L

2. Change of malondialdehyde [change from baseline in malondialdehyde at 7 days and 14 days]

   malondialdehyde in nmol/ml

3. Change of inflammatory factors [change from baseline in fatty acid at 7 days and 14 days]

   IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-α in pg/ml

Other Outcome Measures

1. Change of fatty acids spectrum [change from baseline in fatty acids spectrum at 7 days and 14 days]

   cholic acid, deoxycholic acid,chenodeoxycholic acid,ursodeoxycholic acid and lithocholic acid in mol%,et al.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ying Wang, head of department, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04277923
• Other Study ID Numbers: PNALD
• First Posted: Feb 20, 2020
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ying Wang, head of department, Shanghai Jiao Tong University School of Medicine: parenteral nutrition; lipid emulsion; SMOF; PNALD; oxidative stress
• Additional relevant MeSH terms: Premature Birth; SMOFlipid

Study Results

No Results Posted as of Feb 20, 2020