Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

Study Overview
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Brief Summary
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Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.

Official Title
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Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

Conditions
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Dietary and Nutritional Therapies

Intervention / Treatment
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* Drug: Smoflipid
* Drug: Médialipides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 0-18 years Solid Tumors hematological malignancies Requiring parenteral nutrition during at least 5 days With a central catheter With a normal hepatic function test Exclusion Criteria: Liver function tests disrupted Patient with a tumor or liver metastases Patient with against-indication to the use of lipid

Ages Eligible for Study
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Maximum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Médialipides<br>parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC) | Drug: Médialipides<br> <br> |
| Experimental: SmofLIPID<br>parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC) | Drug: Smoflipid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of γGT in UI/l | to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population. | Baseline | 
| dosage of γGT in UI/l |  | at day 5 | 
| dosage of γGT in UI/l |  | 7 days after the end of parenteral nutrition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asat, alat, PAL, LDH, total bilirubin CRP |  | Baseline | 
| asat, alat, PAL, LDH, total bilirubin CRP |  | at day 5 | 
| asat, alat, PAL, LDH, total bilirubin CRP |  | 7 days after the end of parenteral nutrition | 
| Triglycerids Digestive tolerance (vomiting) |  | Baseline | 
| Triglycerids Digestive tolerance (vomiting) |  | at day 5 | 
| Triglycerids Digestive tolerance (vomiting) |  | 7 days after the end of parenteral nutrition | 
| Infectious episodes (numbers, duration) |  | Baseline | 
| Infectious episodes (numbers, duration) |  | at day 5 | 
| Infectious episodes (numbers, duration) |  | 7 days after the end of parenteral nutrition | 
| Nutritionnal status | (Albumin, weight, BMI) | Baseline | 
| Nutritionnal status | (Albumin, weight, BMI) | at day 5 | 
| Nutritionnal status | (Albumin, weight, BMI) | 7 days after the end of parenteral nutrition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral Nutrition