Hôpital de l'Archet - CHU de Nice
Nice, 06202, France
NCT Number: NCT02539316
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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Notify MeUp to 18 year
All sexes
Interventional
Phase 4
Nice, 06202, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
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.
Time frame: at day 5
Time frame: 7 days after the end of parenteral nutrition
Time frame: Baseline
Time frame: at day 5
Time frame: 7 days after the end of parenteral nutrition
Time frame: Baseline
Time frame: at day 5
Time frame: 7 days after the end of parenteral nutrition
Time frame: Baseline
Time frame: at day 5
Time frame: 7 days after the end of parenteral nutrition
Time frame: Baseline
(Albumin, weight, BMI)
Time frame: at day 5
(Albumin, weight, BMI)
Time frame: 7 days after the end of parenteral nutrition
(Albumin, weight, BMI)
Centre Hospitalier Universitaire de Nice
Other
Acronym: SMOFPILOT
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