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

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Bile Acids and Salts; Soybean oil, phospholipid emulsion

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