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

B. Braun

Status and phase: Completed; Phase 2

Conditions: Preterm Infants; Parenteral Nutrition n-3 Fatty Acids

Treatments: Drug: Lipofundin MCT/LCT 20 %; Drug: Lipidem 20%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00497289

HC-G-H-0404

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 5 hours to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups

1

Experimental group

Description:

Lipidem 20 %

Treatment:

Drug: Lipidem 20%

2

Active Comparator group

Description:

Lipofundin MCT/LCT 20%

Treatment:

Drug: Lipofundin MCT/LCT 20 %