This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
B. Braun Melsungen AG Identifier:
First received: July 4, 2007
Last updated: June 8, 2011
Last verified: June 2011
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 Intervention Phase
Preterm Infants Parenteral Nutrition n-3 Fatty Acids Drug: Lipofundin MCT/LCT 20 % Drug: Lipidem 20% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by B. Braun Melsungen AG:

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

Estimated Enrollment: 34
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Prof. Dr. B. Koletzko, Dr. v. Haunersches Kinderspital Identifier: NCT00497289     History of Changes
Other Study ID Numbers: HC-G-H-0404
Study First Received: July 4, 2007
Last Updated: June 8, 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 processed this record on August 16, 2017