Back to resultsComparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Primary Purpose
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Lipofundin MCT/LCT 20 %
Lipidem 20%
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Infants focused on measuring n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
Eligibility Criteria
Inclusion Criteria:
- prematurity (birth weight 500 - 1500 g)
- postnatal age <= 72 h
- need for cumulative parenteral energy supply of at least 70% during study duration
- signed informed consent form
Exclusion Criteria:
- simultaneous participation in another clinical study
- platelet count below 50000 /ml
- cumulative enteral energy supply of > 30 % during study duration
- serious congenital infections and/or diseases
- serious metabolic disturbances
- severe cranial bleeding (Papile III, IV)
- need for administration of blood products
- contra-indication for iv lipid administration
- withdrawal of consent
Sites / Locations
- Neonatology of the Pediatric University Hospital
- Ernst Moritz Arndt University , Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Lipidem 20 %
Lipofundin MCT/LCT 20%
Outcomes
Primary Outcome Measures
Safety: Alanine Transaminase (ALT)
Change in ALT between pre/post treatment
Efficacy: Interleukin-6 (IL-6)
Change of IL-6 Measurement pre/post treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00497289
Brief Title
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Official Title
Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Keywords
n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Lipidem 20 %
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lipofundin MCT/LCT 20%
Intervention Type
Drug
Intervention Name(s)
Lipofundin MCT/LCT 20 %
Intervention Description
daily i.v. infusion for up to 5 days
Intervention Type
Drug
Intervention Name(s)
Lipidem 20%
Intervention Description
daily i.v. infusion for up to 5 days
Primary Outcome Measure Information:
Title
Safety: Alanine Transaminase (ALT)
Description
Change in ALT between pre/post treatment
Time Frame
on Study day -1 & 6
Title
Efficacy: Interleukin-6 (IL-6)
Description
Change of IL-6 Measurement pre/post treatment
Time Frame
on Study day -1 & 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Hours
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prematurity (birth weight 500 - 1500 g)
postnatal age <= 72 h
need for cumulative parenteral energy supply of at least 70% during study duration
signed informed consent form
Exclusion Criteria:
simultaneous participation in another clinical study
platelet count below 50000 /ml
cumulative enteral energy supply of > 30 % during study duration
serious congenital infections and/or diseases
serious metabolic disturbances
severe cranial bleeding (Papile III, IV)
need for administration of blood products
contra-indication for iv lipid administration
withdrawal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold V. Koletzko, Prof., MD
Organizational Affiliation
Dr. von Hauner Children´s Hospital, University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatology of the Pediatric University Hospital
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80337
Country
Germany
Facility Name
Ernst Moritz Arndt University , Childrens Hospital
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
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