Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
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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 |
- lipometabolism [ Time Frame: Change from Baseline in fatty acid at 7 days and 14 days ] [ Designated as safety issue: Yes ]fatty acid
- 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)
- 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 |
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| Contact: Ying Wang, Phd | 8613611884226 | wangying_ssmu@126.com |
| Contact: Wei Cai, Phd | caiw204@yahoo.com.cn |
| 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 | |
| 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 May 21, 2013