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

Phase 4

Completed

• Conditions: Dietary and Nutritional Therapies
• Interventions: Drug: Smoflipid; Drug: Médialipides

• Registration Number: NCT02539316
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SmofLIPID	Smoflipid	parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)
Médialipides	Médialipides	parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)

Primary Outcome Measures

Name	Time	Method
dosage of γGT in UI/l	7 days after the end of parenteral nutrition

Secondary Outcome Measures

Name	Time	Method
Infectious episodes (numbers, duration)	7 days after the end of parenteral nutrition
asat, alat, PAL, LDH, total bilirubin CRP	7 days after the end of parenteral nutrition
Nutritionnal status	7 days after the end of parenteral nutrition	(Albumin, weight, BMI)
Triglycerids Digestive tolerance (vomiting)	7 days after the end of parenteral nutrition

Trial Locations

Locations (1)

Hôpital de l'Archet - CHU de Nice; 🇫🇷 Nice, France