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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01786759
Other study ID # HFBA
Secondary ID
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


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
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