Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants

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. Identifier: NCT00497289
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : June 9, 2011
Information provided by:
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment Phase
Preterm Infants Parenteral Nutrition n-3 Fatty Acids Drug: Lipofundin MCT/LCT 20 % Drug: Lipidem 20% Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Double-blind, Prospective, Randomized Comparison of a MCT/LCT/FO Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants
Study Start Date : January 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: 1
Lipidem 20 %
Drug: Lipidem 20%
daily i.v. infusion for up to 5 days

Active Comparator: 2
Lipofundin MCT/LCT 20%
Drug: Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days

Primary Outcome Measures :
  1. Safety: Bilirubin, ALT, PTT,Platelet Count [ Time Frame: on Study day -1 & 6 ]
  2. Efficacy: IL-6 [ Time Frame: on Study day -1 & 6 ]

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00497289

Neonatology of the Pediatric University Hospital
Munich, Bavaria, Germany, 80337
Ernst Moritz Arndt University , Childrens Hospital
Greifswald, Germany, 17487
Sponsors and Collaborators
B. Braun Melsungen AG
Principal Investigator: Berthold V. Koletzko, Prof., MD Dr. von Hauner Children´s Hospital, University of Munich

Responsible Party: Prof. Dr. B. Koletzko, Dr. v. Haunersches Kinderspital Identifier: NCT00497289     History of Changes
Other Study ID Numbers: HC-G-H-0404
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by B. Braun Melsungen AG:
n-3 PUFA
parenteral nutrition
preterm infant

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications