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

February 18, 2021 updated by: B. Braun Melsungen AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17487
        • Ernst Moritz Arndt University , Childrens Hospital
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • Neonatology of the Pediatric University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 hours to 3 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Lipidem 20 %
Drug: Lipidem 20%
daily i.v. infusion for up to 5 days
ACTIVE_COMPARATOR: 2
Lipofundin MCT/LCT 20%
Drug: Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Berthold V. Koletzko, Prof., MD, Dr. von Hauner Children´s Hospital, University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

July 4, 2007

First Submitted That Met QC Criteria

July 4, 2007

First Posted (ESTIMATE)

July 6, 2007

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-G-H-0404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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