At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Lipofundin MCT/LCT 20 % +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Lipofundin MCT/LCT 20 % and Lipidem 20% for Preterm Infants and Parenteral Nutrition n-3 Fatty Acids. Completed, enrolled 48 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedJul 2007
Primary CompletionFeb 2008
TodayJul 2026
First PostedJul 6, 2007
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.0 years ago
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