NCT01786759

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
DRUG	ClinOleic	the lipid of all-in-one, 0.5-3.5g/kg.d
DRUG	Intralipid	the lipid of all-in-one, 0.5-3.5g/kg.d

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2013-02-08
• Last updated: 2013-02-08

Locations

1 site across 1 country: China