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

NCT ID: NCT04277923

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2021-08-31

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.

Conditions

Preterm Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

SMOF lipid emulsion

the SMOF lipid emulsion is SMOFlipid.

Group Type: EXPERIMENTAL

SMOFlipid

Intervention Type: DRUG

the lipid of all-in-one is less than 4g/kg.d

MCT/LCT lipid emulsion

the MCT/LCT lipid emulsion is Lipofundin.

Group Type: EXPERIMENTAL

Lipofundin

Intervention Type: DRUG

the lipid of all-in-one is less than 4g/kg.d

Interventions

SMOFlipid

the lipid of all-in-one is less than 4g/kg.d

Intervention Type: DRUG

Lipofundin

the lipid of all-in-one is less than 4g/kg.d

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ying Wang

head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China

Central Contacts

Ying Wang, Phd

Role: CONTACT

wangying_ssmu@126.com

8613611884226

Other Identifiers

PNALD

Identifier Type: -

Identifier Source: org_study_id