Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Preterm Infant

Keywords

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parenteral nutrition lipid emulsion olive oil liver function fatty acid clinical outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olive oil lipid emulsion

the olive oil lipid emulsion is ClinOleic

Group Type EXPERIMENTAL