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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMOF lipid emulsion | Experimental | the SMOF lipid emulsion is SMOFlipid. |
|
| MCT/LCT lipid emulsion | Experimental | the MCT/LCT lipid emulsion is Lipofundin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOFlipid | Drug | the lipid of all-in-one is less than 4g/kg.d |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang, Phd | Contact | 8613611884226 | wangying_ssmu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Wang, Phd | Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China | Principal Investigator |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
| C008288 | Lipofundin |
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| Lipofundin |
| Drug |
the lipid of all-in-one is less than 4g/kg.d |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |