Hepatic Function and Bile Acid in Preterm Infants Receivi... | NCT01786759

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

NCT01786759

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Feb 8, 2013Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Preterm Infants

Interventions

ClinOleic
Intralipid

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

May 2013Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Cai, vice-president, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LCT lipid emulsion	Active Comparator	the LCT lipid emulsion is Intralipid	Drug: ClinOleic Drug: Intralipid
Olive oil lipid emulsion	Experimental	the olive oil lipid emulsion is ClinOleic	Drug: ClinOleic Drug: Intralipid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ClinOleic	Drug	the lipid of all-in-one, 0.5-3.5g/kg.d	LCT lipid emulsion Olive oil lipid emulsion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	Change from Baseline in fatty acid at 7 days and 14 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Wang, PhD	Contact	8613611884226		wangying_ssmu@126.com

Overall Officials

Name	Affiliation	Role
Wei Cai, PhD	Xin Hua Hospital of Zhejiang Province	Study Chair
Ying Wang, PhD	Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinhua hospital	Recruiting	Shanghai	Shanghai Municipality	200092	China

Condition Browse Module

MeSH Terms

ID	Term
D006963	Hyperphagia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C568346	ClinOleic
C545823	soybean oil, phospholipid emulsion

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided