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

NCT ID: NCT02539316

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-10-31

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.

Conditions

Dietary and Nutritional Therapies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Médialipides

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

Group Type: ACTIVE_COMPARATOR

Médialipides

Intervention Type: DRUG

SmofLIPID

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

Group Type: EXPERIMENTAL

Smoflipid

Intervention Type: DRUG

Interventions

Smoflipid

Intervention Type: DRUG

Médialipides

Intervention Type: DRUG

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de l'Archet - CHU de Nice

Nice, , France

Countries

France

Other Identifiers

15-PP-03

Identifier Type: -

Identifier Source: org_study_id