Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.

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

Details

• Lead Sponsor: Wei Cai
• Treatments: 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

• 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

• CMV, virus hepatitis and syphilis infection

• Congenital or acquired immune deficiency