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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 4

Conditions: Dietary and Nutritional Therapies

Treatments: Drug: Médialipides; Drug: Smoflipid

Study type: Interventional

Funder types: Other

Identifiers

NCT02539316

15-PP-03

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Médialipides

Active Comparator group

Description:

parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)

Treatment:

Drug: Médialipides

SmofLIPID

Experimental group

Description:

parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)

Treatment:

Drug: Smoflipid