Clinical trial NCT01786759: Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Official title: Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preterm Infants
Keywords: lipids
preterm infants
parenteral nutrition
liver function
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: liver function
timeFrame: Change from Baseline in fatty acid at 7 days and 14 days
Secondary outcomes:
measure: bile acid
timeFrame: Change from Baseline in fatty acid at 7 days and 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua hospital
state: Shanghai
Study officials:
affiliation: Xin Hua Hospital
name: Wei Cai, PhD
role: STUDY_CHAIR
affiliation: Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
name: Ying Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: