Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation

Study Overview
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Brief Summary
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Background and Aims: Nutritional support is considered an integral part of the supportive care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare plasma cytokines levels in children after bone marrow transplantation using a lipid formula enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition. Methods: A randomized double blinded controlled study including 14 children with BMT and requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha (TNF-α).

Conditions
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Bone Narrow Transplantation

Intervention / Treatment
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* Dietary Supplement: Formula with soybean oil, medium-chain triglycerides
* Dietary Supplement: Soybean oil formula commonly used in the hospital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term infants. Children with a stable medical condition. Children in need of parenteral nutrition for at least 10 days, except for the cardiac group would be at least 5 days. Exclusion Criteria: Premature infants Children over 14 years Children with hypersensitivity to egg ingestion or soy protein Children with severe insufficiency of an organ, Children with inborn error of metabolism, and any condition that does not allow random use of lipid emulsion type.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soybean oil formula commonly used in the hospita<br> | Dietary Supplement: Soybean oil formula commonly used in the hospital<br> <br> |
| Experimental: Formula with soybean oil, medium-chain triglyce<br> | Dietary Supplement: Formula with soybean oil, medium-chain triglycerides<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average cytokines plasma levels between groups of children with the two different lipid formulas. | The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements such as: weight height |  | 21 days | 
| Incidence of adverse effects associated with formula consumption. |  | 21 days |