Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683162
Recruitment Status : Unknown
Verified September 2012 by Wei Cai, Shanghai Jiao Tong University.
Recruitment status was:  Recruiting
First Posted : September 11, 2012
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
Wei Cai, Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Preterm Infant Drug: ClinOleic Drug: Lipofundin Drug: Intralipid Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
Study Start Date : July 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. lipometabolism [ Time Frame: Change from Baseline in fatty acid at 7 days and 14 days ]
    fatty acid

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

Other Outcome Measures:
  1. clinical outcomes [ Time Frame: before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
    the growth of weight and head circumference, days on ventilator, length of hospitalization, morbidity of sepsis and NEC

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683162

Contact: Ying Wang, Phd 8613611884226
Contact: Wei Cai, Phd

China, Shanghai
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200092
Contact: Ying Wang, Phd    8613611884226   
Contact: Wei Cai, Phd   
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
Principal Investigator: Ying Wang, phd Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wei Cai, vice-president, Shanghai Jiao Tong University Identifier: NCT01683162     History of Changes
Other Study ID Numbers: PNDLEIPI
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Wei Cai, Shanghai Jiao Tong University:
parenteral nutrition
lipid emulsion
olive oil
liver function
fatty acid
clinical outcomes

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions