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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00497289
First received: July 4, 2007
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Efficacy: IL-6 [ Time Frame: on Study day -1 & 6 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497289

Locations
Germany
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
Investigators
Principal Investigator: Berthold V. Koletzko, Prof., MD Dr. von Hauner Children´s Hospital, University of Munich
  More Information

No publications provided

Responsible Party: Prof. Dr. B. Koletzko, Dr. v. Haunersches Kinderspital
ClinicalTrials.gov Identifier: NCT00497289     History of Changes
Other Study ID Numbers: HC-G-H-0404
Study First Received: July 4, 2007
Last Updated: June 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013