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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG

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