Preterm Infant
Conditions
Keywords
parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress
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.
Interventions
DRUGSMOFlipid
the lipid of all-in-one is less than 4g/kg.d
DRUGLipofundin
the lipid of all-in-one is less than 4g/kg.d
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of liver function indexes | change from baseline in liver function indexes at 7 days and 14 days | liver enzyme in u/L |
| Change of bilirubin indexes | change from baseline in bilirubin indexes at 7 days and 14 days | bilirubin in μmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of superoxidase dismutase | change from baseline in superoxidase dismutase at 7 days and 14 days | superoxidase dismutase in u/L |
| Change of malondialdehyde | change from baseline in malondialdehyde at 7 days and 14 days | malondialdehyde in nmol/ml |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactYing Wang, Phd
Outcome results
None listed