Phase 2 N=48 Randomized Double-blind Prevention

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

Preterm Infants · Parenteral Nutrition n-3 Fatty Acids

Bottom Line

View on ClinicalTrials.gov: NCT00497289 ↗

Enrolled (actual)

Serious AEs

85.4%

Results posted

Mar 2021

Primary outcome: Primary: Safety: Alanine Transaminase (ALT) — -0.83; -3.27 U/L — p=0.3654

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lipofundin MCT/LCT 20 % (Drug); Lipidem 20% (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: B. Braun Melsungen AG
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety: Alanine Transaminase (ALT)	-0.83; -3.27	0.3654
PRIMARY Efficacy: Interleukin-6 (IL-6)	-42.23; -68.74	0.0264 sig

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.

Eligibility Criteria

Inclusion Criteria

prematurity (birth weight 500 - 1500 g)
postnatal age 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

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Data sourced from ClinicalTrials.gov (NCT00497289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.