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

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.

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Key information

Conditions

Preterm Infants Female Urogenital Diseases and Pregnancy Complications Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Parenteral Nutrition n-3 Fatty Acids Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

5 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neonatology of the Pediatric University Hospital, Munich, Bavaria, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Safety: Alanine Transaminase (ALT)

Time frame: on Study day -1 & 6

Change in ALT between pre/post treatment
Efficacy: Interleukin-6 (IL-6)

Time frame: on Study day -1 & 6

Change of IL-6 Measurement pre/post treatment

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 6, 2007
Registry last updated: Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed