Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Infant
• Intervention / Treatment: Drug: ClinOleic; Drug: Intralipid; Drug: Lipofundin

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
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei Cai, Phd; Email: caiw204@yahoo.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
      • Principal Investigator: Wei Cai, Phd
      • Principal Investigator: Ying Wang, Phd
      • Contact: Wei Cai, Phd; Email: caiw204@yahoo.com.cn
      • Sub-Investigator: Qing-ya Tang, MD
      • Sub-Investigator: Li-na Lu, MD
      • Principal Investigator: Li Hong, Phd
      • Sub-Investigator: Yi Feng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipometabolism	fatty acid	Change from Baseline in fatty acid at 7 days and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxidative stress	superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)	Change from Baseline in liver function at 7 days and 14 days

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wei Cai
• Investigators: Principal Investigator: Ying Wang, phd, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): February 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (ESTIMATE): September 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 15, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: olive oil; lipid emulsion; clinical outcomes; fatty acid; liver function; parenteral nutrition
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: PNDLEIPI