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

B. Braun Melsungen AG48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Preterm Infants Parenteral Nutrition n-3 Fatty Acids

Interventions

Lipofundin MCT/LCT 20 %DRUG

daily i.v. infusion for up to 5 days

Lipidem 20%DRUG

daily i.v. infusion for up to 5 days

Eligibility

Sex: ALLMin age: 5 HoursMax age: 3 Days

Medical Language ↔ Plain English

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

Locations (2)

Neonatology of the Pediatric University Hospital

Munich, Bavaria, Germany

Ernst Moritz Arndt University , Childrens Hospital

Greifswald, Germany

Outcomes

Primary Outcomes

Safety: Alanine Transaminase (ALT)

Change in ALT between pre/post treatment

Time frame: on Study day -1 & 6

Efficacy: Interleukin-6 (IL-6)

Change of IL-6 Measurement pre/post treatment

Time frame: on Study day -1 & 6

Data from ClinicalTrials.gov

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