Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
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
1 other identifier
interventional
48
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 4, 2007
CompletedFirst Posted
Study publicly available on registry
July 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
March 10, 2021
CompletedMarch 10, 2021
February 1, 2021
2.1 years
July 4, 2007
January 7, 2021
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety: Alanine Transaminase (ALT)
Change in ALT between pre/post treatment
on Study day -1 & 6
Efficacy: Interleukin-6 (IL-6)
Change of IL-6 Measurement pre/post treatment
on Study day -1 & 6
Study Arms (2)
1
EXPERIMENTALLipidem 20 %
2
ACTIVE COMPARATORLipofundin MCT/LCT 20%
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Neonatology of the Pediatric University Hospital
Munich, Bavaria, 80337, Germany
Ernst Moritz Arndt University , Childrens Hospital
Greifswald, 17487, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study manager
- Organization
- B.Braun Melsungen AG
Study Officials
- PRINCIPAL INVESTIGATOR
Berthold V. Koletzko, Prof., MD
Dr. von Hauner Children´s Hospital, University of Munich
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2007
First Posted
July 6, 2007
Study Start
January 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
March 10, 2021
Results First Posted
March 10, 2021
Record last verified: 2021-02