Clinical trial NCT02539316: Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
Official title: Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dietary and Nutritional Therapies
Keywords: Parenteral Nutrition
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 9
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: dosage of γGT in UI/l
timeFrame: Baseline
measure: dosage of γGT in UI/l
timeFrame: at day 5
measure: dosage of γGT in UI/l
timeFrame: 7 days after the end of parenteral nutrition
Secondary outcomes:
measure: asat, alat, PAL, LDH, total bilirubin CRP
timeFrame: Baseline
measure: asat, alat, PAL, LDH, total bilirubin CRP
timeFrame: at day 5
measure: asat, alat, PAL, LDH, total bilirubin CRP
timeFrame: 7 days after the end of parenteral nutrition
measure: Triglycerids Digestive tolerance (vomiting)
timeFrame: Baseline
measure: Triglycerids Digestive tolerance (vomiting)
timeFrame: at day 5
measure: Triglycerids Digestive tolerance (vomiting)
timeFrame: 7 days after the end of parenteral nutrition
measure: Infectious episodes (numbers, duration)
timeFrame: Baseline
measure: Infectious episodes (numbers, duration)
timeFrame: at day 5
measure: Infectious episodes (numbers, duration)
timeFrame: 7 days after the end of parenteral nutrition
measure: Nutritionnal status
timeFrame: Baseline
measure: Nutritionnal status
timeFrame: at day 5
measure: Nutritionnal status
timeFrame: 7 days after the end of parenteral nutrition
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital de l'Archet - CHU de Nice
Study officials:
References: