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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olive oil lipid emulsion | Experimental | the olive oil lipid emulsion is ClinOleic |
|
| MCT/LCT lipid emulsion | Experimental | the MCT/LCT lipid emulsion is Lipofundin |
|
| LCT lipid emulsion | Experimental | the LCT lipid emulsion is Intralipid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClinOleic | Drug | the lipid of all-in-one, 0.5-3.5g/kg.d |
| |
| Measure | Description | Time Frame |
|---|---|---|
| lipometabolism | fatty acid | Change from Baseline in fatty acid at 7 days and 14 days |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang, Phd | Contact | 8613611884226 | wangying_ssmu@126.com | |
| Wei Cai, Phd | Contact | caiw204@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ying Wang, phd | Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26561301 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C568346 | ClinOleic |
| C008288 | Lipofundin |
| C545823 | soybean oil, phospholipid emulsion |
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| Lipofundin |
| Drug |
the lipid of all-in-one, 0.5-3.5g/kg.d |
|
| Intralipid | Drug | the lipid of all-in-one, 0.5-3.5g/kg.d |
|
| D000091642 | Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |