MedTrace Logo

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

NCT00497289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-03-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Preterm Infants
  • Parenteral Nutrition n-3 Fatty Acids

Interventions

DRUG

Lipofundin MCT/LCT 20 %

daily i.v. infusion for up to 5 days

DRUG

Lipidem 20%

daily i.v. infusion for up to 5 days

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Hours
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00497289 on ClinicalTrials.gov