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NCT00497289 Clinical Trial

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

Preterm Infants Clinical Trial

Official title:
Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00497289
Other study ID # HC-G-H-0404
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2006
Est. completion date February 2008

Study information
Verified date February 2021
Source B. Braun Melsungen AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days
• Lipidem 20%
daily i.v. infusion for up to 5 days

Locations
Country Name City State
Germany Ernst Moritz Arndt University , Childrens Hospital Greifswald
Germany Neonatology of the Pediatric University Hospital Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: Alanine Transaminase (ALT) Change in ALT between pre/post treatment on Study day -1 & 6
Primary Efficacy: Interleukin-6 (IL-6) Change of IL-6 Measurement pre/post treatment on Study day -1 & 6
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