Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Phase 2
Completed
- Conditions
- Parenteral Nutrition n-3 Fatty AcidsPreterm Infants
- Interventions
- Drug: Lipidem 20%Drug: Lipofundin MCT/LCT 20 %
- Registration Number
- NCT00497289
- Lead Sponsor
- B. Braun Melsungen AG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lipidem 20% Lipidem 20 % 2 Lipofundin MCT/LCT 20 % Lipofundin MCT/LCT 20%
- Primary Outcome Measures
Name Time Method Efficacy: Interleukin-6 (IL-6) on Study day -1 & 6 Change of IL-6 Measurement pre/post treatment
Safety: Alanine Transaminase (ALT) on Study day -1 & 6 Change in ALT between pre/post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Neonatology of the Pediatric University Hospital
🇩🇪Munich, Bavaria, Germany
Ernst Moritz Arndt University , Childrens Hospital
🇩🇪Greifswald, Germany