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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Médialipides | Active Comparator | parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC) |
|
| SmofLIPID | Experimental | parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoflipid | Drug |
| ||
| Médialipides |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de l'Archet - CHU de Nice | Nice | 06202 | France |
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|
| 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 |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
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