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

NCT02539316 | Completed Phase 4

• 1 other identifier: 15-PP-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Parenteral Nutrition

Outcome Measures

Primary Outcomes (3)

• dosage of γGT in UI/l

  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.

  Baseline

• dosage of γGT in UI/l

  at day 5

• dosage of γGT in UI/l

  7 days after the end of parenteral nutrition

Secondary Outcomes (12)

• asat, alat, PAL, LDH, total bilirubin CRP

  Baseline

• asat, alat, PAL, LDH, total bilirubin CRP

  at day 5

• asat, alat, PAL, LDH, total bilirubin CRP

  7 days after the end of parenteral nutrition

• Triglycerids Digestive tolerance (vomiting)

  Baseline

• Triglycerids Digestive tolerance (vomiting)

  at day 5

Study Arms (2)

Médialipides

ACTIVE COMPARATOR

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

Drug: Médialipides

SmofLIPID

EXPERIMENTAL

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

Drug: Smoflipid

Interventions

Smoflipid DRUG

SmofLIPID

Médialipides DRUG

Médialipides

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• Solid Tumors
• hematological malignancies
• Requiring parenteral nutrition during at least 5 days
• With a central catheter
• With a normal hepatic function test

You may not qualify if:

• Liver function tests disrupted
• Patient with a tumor or liver metastases
• Patient with against-indication to the use of lipid

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital de l'Archet - CHU de Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Hyperphagia

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 3, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

FR (1)