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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786759
• Other study ID #: HFBA
• Status: Recruiting
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: February 6, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ying Wang, PhD
• Phone: 8613611884226
• Email: wangying_ssmu[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Drug:
• ClinOleic
the lipid of all-in-one, 0.5-3.5g/kg.d
• Intralipid
the lipid of all-in-one, 0.5-3.5g/kg.d

Locations

Country	Name	City	State
China	Xinhua hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver function	Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),?-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)	Change from Baseline in fatty acid at 7 days and 14 days	Yes
Secondary	bile acid	cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.	Change from Baseline in fatty acid at 7 days and 14 days	No