Clinical trial NCT04277923: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preterm Infant
Keywords: parenteral nutrition
lipid emulsion
SMOF
PNALD
oxidative stress
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of liver function indexes
timeFrame: change from baseline in liver function indexes at 7 days and 14 days
measure: Change of bilirubin indexes
timeFrame: change from baseline in bilirubin indexes at 7 days and 14 days
Secondary outcomes:
measure: Change of superoxidase dismutase
timeFrame: change from baseline in superoxidase dismutase at 7 days and 14 days
measure: Change of malondialdehyde
timeFrame: change from baseline in malondialdehyde at 7 days and 14 days
measure: Change of inflammatory factors
timeFrame: change from baseline in fatty acid at 7 days and 14 days
Other outcomes:
measure: Change of fatty acids spectrum
timeFrame: change from baseline in fatty acids spectrum at 7 days and 14 days
Locations:
Study officials:
affiliation: Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China
name: Ying Wang, Phd
role: PRINCIPAL_INVESTIGATOR
References: