Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02539316
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dietary and Nutritional Therapies Drug: Smoflipid Drug: Médialipides Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. dosage of γGT in UI/l [ Time Frame: at day 5 ]
  3. dosage of γGT in UI/l [ Time Frame: 7 days after the end of parenteral nutrition ]

Secondary Outcome Measures :
  1. asat, alat, PAL, LDH, total bilirubin CRP [ Time Frame: Baseline ]
  2. asat, alat, PAL, LDH, total bilirubin CRP [ Time Frame: at day 5 ]
  3. asat, alat, PAL, LDH, total bilirubin CRP [ Time Frame: 7 days after the end of parenteral nutrition ]
  4. Triglycerids Digestive tolerance (vomiting) [ Time Frame: Baseline ]
  5. Triglycerids Digestive tolerance (vomiting) [ Time Frame: at day 5 ]
  6. Triglycerids Digestive tolerance (vomiting) [ Time Frame: 7 days after the end of parenteral nutrition ]
  7. Infectious episodes (numbers, duration) [ Time Frame: Baseline ]
  8. Infectious episodes (numbers, duration) [ Time Frame: at day 5 ]
  9. Infectious episodes (numbers, duration) [ Time Frame: 7 days after the end of parenteral nutrition ]
  10. Nutritionnal status [ Time Frame: Baseline ]
    (Albumin, weight, BMI)

  11. Nutritionnal status [ Time Frame: at day 5 ]
    (Albumin, weight, BMI)

  12. Nutritionnal status [ Time Frame: 7 days after the end of parenteral nutrition ]
    (Albumin, weight, BMI)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539316


Locations
Layout table for location information
France
Hôpital de l'Archet - CHU de Nice
Nice, France, 06202
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02539316     History of Changes
Other Study ID Numbers: 15-PP-03
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Centre Hospitalier Universitaire de Nice:
Parenteral Nutrition