Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Wei Cai, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT01683162
First received: July 18, 2012
Last updated: September 15, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Preterm Infant
Drug: ClinOleic
Drug: Lipofundin
Drug: Intralipid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • lipometabolism [ Time Frame: Change from Baseline in fatty acid at 7 days and 14 days ] [ Designated as safety issue: Yes ]
    fatty acid


Secondary Outcome Measures:
  • oxidative stress [ Time Frame: Change from Baseline in liver function at 7 days and 14 days ] [ Designated as safety issue: Yes ]
    superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)


Other Outcome Measures:
  • clinical outcomes [ Time Frame: before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    the growth of weight and head circumference, days on ventilator, length of hospitalization, morbidity of sepsis and NEC


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olive oil lipid emulsion
the olive oil lipid emulsion is ClinOleic
Drug: ClinOleic
the lipid of all-in-one, 0.5-3.5g/kg.d
Experimental: MCT/LCT lipid emulsion
the MCT/LCT lipid emulsion is Lipofundin
Drug: Lipofundin
the lipid of all-in-one, 0.5-3.5g/kg.d
Experimental: LCT lipid emulsion
the LCT lipid emulsion is Intralipid
Drug: Intralipid
the lipid of all-in-one, 0.5-3.5g/kg.d

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683162

Contacts
Contact: Ying Wang, Phd 8613611884226 wangying_ssmu@126.com
Contact: Wei Cai, Phd caiw204@yahoo.com.cn

Locations
China, Shanghai
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200092
Contact: Ying Wang, Phd    8613611884226    wangying_ssmu@126.com   
Contact: Wei Cai, Phd       caiw204@yahoo.com.cn   
Principal Investigator: Ying Wang, Phd         
Sub-Investigator: Qing-ya Tang, MD         
Sub-Investigator: Li-na Lu, MD         
Principal Investigator: Wei Cai, Phd         
Principal Investigator: Li Hong, Phd         
Sub-Investigator: Yi Feng         
Sponsors and Collaborators
Wei Cai
Investigators
Principal Investigator: Ying Wang, phd Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China
  More Information

No publications provided

Responsible Party: Wei Cai, vice-president, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01683162     History of Changes
Other Study ID Numbers: PNDLEIPI
Study First Received: July 18, 2012
Last Updated: September 15, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Jiao Tong University School of Medicine:
parenteral nutrition
lipid emulsion
olive oil
liver function
fatty acid
clinical outcomes

ClinicalTrials.gov processed this record on July 23, 2014