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

Primary Purpose

Preterm Infants

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ClinOleic
Intralipid
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Infants focused on measuring lipids, preterm infants, parenteral nutrition, liver function

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xinhua hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LCT lipid emulsion

Olive oil lipid emulsion

Arm Description

the LCT lipid emulsion is Intralipid

the olive oil lipid emulsion is ClinOleic

Outcomes

Primary Outcome Measures

liver function
Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)

Secondary Outcome Measures

bile acid
cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.

Full Information

First Posted
February 6, 2013
Last Updated
February 6, 2013
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01786759
Brief Title
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Official Title
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
lipids, preterm infants, parenteral nutrition, liver function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LCT lipid emulsion
Arm Type
Active Comparator
Arm Description
the LCT lipid emulsion is Intralipid
Arm Title
Olive oil lipid emulsion
Arm Type
Experimental
Arm Description
the olive oil lipid emulsion is ClinOleic
Intervention Type
Drug
Intervention Name(s)
ClinOleic
Intervention Description
the lipid of all-in-one, 0.5-3.5g/kg.d
Intervention Type
Drug
Intervention Name(s)
Intralipid
Intervention Description
the lipid of all-in-one, 0.5-3.5g/kg.d
Primary Outcome Measure Information:
Title
liver function
Description
Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)
Time Frame
Change from Baseline in fatty acid at 7 days and 14 days
Secondary Outcome Measure Information:
Title
bile acid
Description
cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.
Time Frame
Change from Baseline in fatty acid at 7 days and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, PhD
Phone
8613611884226
Email
wangying_ssmu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Cai, PhD
Organizational Affiliation
Xin Hua Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ying Wang, PhD
Organizational Affiliation
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yexuan Tao, PhD
Phone
13818334664
Email
taoyexuan@hotmail.cm
First Name & Middle Initial & Last Name & Degree
Wei Cai, PhD
First Name & Middle Initial & Last Name & Degree
Ying Wang, PhD
First Name & Middle Initial & Last Name & Degree
Kejun Zhou, PhD
First Name & Middle Initial & Last Name & Degree
Qingya Tang, MD
First Name & Middle Initial & Last Name & Degree
Lina Lu, PhD

12. IPD Sharing Statement

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

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