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

April 12, 2017 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06202
        • Hôpital de l'Archet - CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Médialipides
parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)
Drug: Médialipides
EXPERIMENTAL: SmofLIPID
parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)
Drug: Smoflipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dosage of γGT in UI/l
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.
Baseline
dosage of γGT in UI/l
Time Frame: at day 5
at day 5
dosage of γGT in UI/l
Time Frame: 7 days after the end of parenteral nutrition
7 days after the end of parenteral nutrition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asat, alat, PAL, LDH, total bilirubin CRP
Time Frame: Baseline
Baseline
asat, alat, PAL, LDH, total bilirubin CRP
Time Frame: at day 5
at day 5
asat, alat, PAL, LDH, total bilirubin CRP
Time Frame: 7 days after the end of parenteral nutrition
7 days after the end of parenteral nutrition
Triglycerids Digestive tolerance (vomiting)
Time Frame: Baseline
Baseline
Triglycerids Digestive tolerance (vomiting)
Time Frame: at day 5
at day 5
Triglycerids Digestive tolerance (vomiting)
Time Frame: 7 days after the end of parenteral nutrition
7 days after the end of parenteral nutrition
Infectious episodes (numbers, duration)
Time Frame: Baseline
Baseline
Infectious episodes (numbers, duration)
Time Frame: at day 5
at day 5
Infectious episodes (numbers, duration)
Time Frame: 7 days after the end of parenteral nutrition
7 days after the end of parenteral nutrition
Nutritionnal status
Time Frame: Baseline
(Albumin, weight, BMI)
Baseline
Nutritionnal status
Time Frame: at day 5
(Albumin, weight, BMI)
at day 5
Nutritionnal status
Time Frame: 7 days after the end of parenteral nutrition
(Albumin, weight, BMI)
7 days after the end of parenteral nutrition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (ESTIMATE)

September 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-PP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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