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Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

Primary Purpose

Preterm Infant

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ClinOleic
Lipofundin
Intralipid
Sponsored by
Wei Cai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring parenteral nutrition, lipid emulsion, olive oil, liver function, fatty acid, clinical outcomes

Eligibility Criteria

1 Day - 1 Year (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
  • 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
  • CMV, virus hepatitis and syphilis infection
  • Congenital or acquired immune deficiency

Sites / Locations

  • Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Olive oil lipid emulsion

MCT/LCT lipid emulsion

LCT lipid emulsion

Arm Description

the olive oil lipid emulsion is ClinOleic

the MCT/LCT lipid emulsion is Lipofundin

the LCT lipid emulsion is Intralipid

Outcomes

Primary Outcome Measures

lipometabolism
fatty acid

Secondary Outcome Measures

oxidative stress
superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)

Full Information

First Posted
July 18, 2012
Last Updated
September 15, 2012
Sponsor
Wei Cai
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1. Study Identification

Unique Protocol Identification Number
NCT01683162
Brief Title
Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
Official Title
Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Cai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.
Detailed Description
For a number of years, lipid emulsions have been used in the nutritional support of surgical and critically ill patients, with the aim of supplying substrates to meet energy demands and providing building blocks for wound healing and tissue repair. 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), 62% of which are polyunsaturated fatty acids (PUFAs), 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 PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations with olive oil-based emulsion including in-vitro studies, animal studies, and infusion studies in healthy subjects and in various patient groups. In-vitro and animal studies demonstrate that the impairment of immune function, especially of T cell responses, that occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and adults have consistently shown that olive oil-based emulsion increases the oleic acid content of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies are required to test their beneficial effect from olive oil consumption in preterm infants. The investigators designed a double-blind, randomized clinical trial to performed the effect of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT lipid emulsions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
Keywords
parenteral nutrition, lipid emulsion, olive oil, liver function, fatty acid, clinical outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olive oil lipid emulsion
Arm Type
Experimental
Arm Description
the olive oil lipid emulsion is ClinOleic
Arm Title
MCT/LCT lipid emulsion
Arm Type
Experimental
Arm Description
the MCT/LCT lipid emulsion is Lipofundin
Arm Title
LCT lipid emulsion
Arm Type
Experimental
Arm Description
the LCT lipid emulsion is Intralipid
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)
Lipofundin
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
lipometabolism
Description
fatty acid
Time Frame
Change from Baseline in fatty acid at 7 days and 14 days
Secondary Outcome Measure Information:
Title
oxidative stress
Description
superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)
Time Frame
Change from Baseline in liver function at 7 days and 14 days
Other Pre-specified Outcome Measures:
Title
clinical outcomes
Description
the growth of weight and head circumference, days on ventilator, length of hospitalization, morbidity of sepsis and NEC
Time Frame
before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
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 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 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
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Cai, Phd
Email
caiw204@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Wang, phd
Organizational Affiliation
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang, Phd
Phone
8613611884226
Email
wangying_ssmu@126.com
First Name & Middle Initial & Last Name & Degree
Wei Cai, Phd
Email
caiw204@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Ying Wang, Phd
First Name & Middle Initial & Last Name & Degree
Qing-ya Tang, MD
First Name & Middle Initial & Last Name & Degree
Li-na Lu, MD
First Name & Middle Initial & Last Name & Degree
Wei Cai, Phd
First Name & Middle Initial & Last Name & Degree
Li Hong, Phd
First Name & Middle Initial & Last Name & Degree
Yi Feng

12. IPD Sharing Statement

Citations:
PubMed Identifier
26561301
Citation
Wang Y, Feng Y, Lu LN, Wang WP, He ZJ, Xie LJ, Hong L, Tang QY, Cai W. The effects of different lipid emulsions on the lipid profile, fatty acid composition, and antioxidant capacity of preterm infants: A double-blind, randomized clinical trial. Clin Nutr. 2016 Oct;35(5):1023-31. doi: 10.1016/j.clnu.2015.10.011. Epub 2015 Oct 31.
Results Reference
derived

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Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

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