drugset / Trial / NCT03275090

The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis

NCT03275090

Phase 4 Completed 40 enrolled Mansoura University Children Hospital
RandomizedParallel-groupTriple-blindHealth-services research

Summary

Introduction and objectives: Lipid emulsions play an important role in parenteral nutrition in preterm infants. We aim to evaluate the effect of two different intravenous lipid emulsions on the outcomes of neonatal sepsis in preterm infants. Methods: A randomized controlled trial is conducted in the Neonatal Care Unit of Mansoura University Children's Hospital, Egypt. Forty preterm infants with clinically suspected sepsis are enrolled and assigned randomly into one of two groups, one receive MOFS lipid emulsion (MOFS group) and the other receive pure soyabean oil-based emulsion (S group). Clinical and epidemiological data are collected. Assessment is done on 1st day and 7th day post randomization including growth parameters, complete blood count, C-reactive protein, random blood glucose, serum creatinine, serum triglyceride, soluble intercellular adhesion molecule 1 (sICAM-1) and leukocyte integrin β2. Between-groups and within-group differences will be analyzed statistically.

Timeline

Start
2016-02-01
Primary completion
2017-01-02
Completion
2017-02-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator SMOFlipid Other / unclassified 3.5 g/kg

Indications