Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion

Study Overview
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Brief Summary
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The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Detailed Description
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Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD). Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Official Title
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Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion

Conditions
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Preterm Infants

Intervention / Treatment
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* Drug: ClinOleic
* Drug: Intralipid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants of both genders Hospitalized The parent of the infant agreed to participate by signing an informed consent form Infants admitted hospital within 72 hours after birth(gestational age<37 weeks) Birth weight <= 2000g No PN support contraindications Parenteral nutrition for 14 days or more The parent of the infant is to sign an informed consent form prior to enrollment Exclusion Criteria: Receiving PN before screening Enteral nutrition(EN)caloric>10% Obstruction jaundice Suspected or identified biliary tract atresia Neonatal hepatitis Infants with liver markers >2 times normal levels Infants with renal markers >2 times normal levels Congenital metabolic situations Identified as having major chromosomal disease Cytomegaoviyns(CMV), virus hepatitis and syphilis infection Congenital or acquired immune deficiency

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LCT lipid emulsion<br>the LCT lipid emulsion is Intralipid | Drug: ClinOleic<br>* the lipid of all-in-one, 0.5-3.5g/kg.d<br>Drug: Intralipid<br>* the lipid of all-in-one, 0.5-3.5g/kg.d<br>|
| Experimental: Olive oil lipid emulsion<br>the olive oil lipid emulsion is ClinOleic | Drug: ClinOleic<br>* the lipid of all-in-one, 0.5-3.5g/kg.d<br>Drug: Intralipid<br>* the lipid of all-in-one, 0.5-3.5g/kg.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function | Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi) | Change from Baseline in fatty acid at 7 days and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bile acid | cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al. | Change from Baseline in fatty acid at 7 days and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipids, preterm infants, parenteral nutrition, liver function