Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 8, 2013
February 1, 2013
7 months
February 6, 2013
February 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
bile acid
Change from Baseline in fatty acid at 7 days and 14 days
Study Arms (2)
LCT lipid emulsion
ACTIVE COMPARATORthe LCT lipid emulsion is Intralipid
Olive oil lipid emulsion
EXPERIMENTALthe olive oil lipid emulsion is ClinOleic
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua hospital
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei Cai, PhD
Xin Hua Hospital
- PRINCIPAL INVESTIGATOR
Ying Wang, PhD
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice-president
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 8, 2013
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
February 8, 2013
Record last verified: 2013-02