Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants - Full Text View

Sponsor:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00497289

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

Drug Information available for: Lipids

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
1: Experimental Lipidem 20 %	Drug: Lipidem 20% daily i.v. infusion for up to 5 days
2: Active Comparator 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, Bavaria
Neonatology of the Pediatric University Hospital
Munich, Bavaria, Germany, 80337
Germany
Ernst Moritz Arndt University , Childrens Hospital
Greifswald, Germany, 17487

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Study Director:	Susanne Mientus, PhD	B. Braun Melsungen AG
Principal Investigator:	Berthold V. Koletzko, Prof., MD	Dr. von Hauner Children´s Hospital, University of Munich

More Information

No publications provided

Responsible Party:	Dr. v. Haunersches Kinderspital ( Prof. Dr. B. Koletzko )
ClinicalTrials.gov Identifier:	NCT00497289 History of Changes
Other Study ID Numbers:	HC-G-H-0404
Study First Received:	July 4, 2007
Last Updated:	April 24, 2008
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 September 07, 2010