Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
NCT ID: NCT00497289
Last Updated: 2021-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2006-01-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Lipidem 20 %
Lipidem 20%
daily i.v. infusion for up to 5 days
2
Lipofundin MCT/LCT 20%
Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days
Interventions
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Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days
Lipidem 20%
daily i.v. infusion for up to 5 days
Eligibility Criteria
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Inclusion Criteria
* postnatal age \<= 72 h
* need for cumulative parenteral energy supply of at least 70% during study duration
* signed informed consent form
Exclusion Criteria
* 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
5 Hours
3 Days
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
Responsible Party
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Principal Investigators
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Berthold V. Koletzko, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Dr. von Hauner Children´s Hospital, University of Munich
Locations
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Neonatology of the Pediatric University Hospital
Munich, Bavaria, Germany
Ernst Moritz Arndt University , Childrens Hospital
Greifswald, , Germany
Countries
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Other Identifiers
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HC-G-H-0404
Identifier Type: -
Identifier Source: org_study_id
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