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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Preterm Infants

Treatments: Drug: ClinOleic; Drug: Intralipid

Study type: Interventional

Funder types: Other

Identifiers

NCT01786759

HFBA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

LCT lipid emulsion

Active Comparator group

Description:

the LCT lipid emulsion is Intralipid

Treatment:

Drug: Intralipid

Drug: ClinOleic

Olive oil lipid emulsion

Experimental group

Description:

the olive oil lipid emulsion is ClinOleic

Treatment:

Drug: Intralipid

Drug: ClinOleic