The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis: a Randomized Pilot Controlled Trial

1. Introduction Neonatal sepsis is a clinical syndrome of bacteremia with systemic symptoms and signs of infection in the first 28 days of life. In recent national studies, the incidence of suspected neonatal sepsis among admitted neonates varied from 32.9% to 45.9% with a higher incidence in preterm.

Several soluble adhesion molecules are released in neonatal sepsis. Among these, soluble intercellular adhesion molecule 1 (sICAM-1) and leukocyte integrin β2 are early predictors of sepsis with high sensitivity and specificity.

Septic preterm infants are more vulnerable to undernutrition and postnatal failure of growth requiring more nutritional support. The early use of adequate parenteral nutrition (PN) minimizes weight loss, improves growth and neurodevelopmental outcomes, and appears to reduce the risk of mortality. In preterm neonates, lipid emulsions (LE) play an important role in PN being an important source of energy, fat soluble vitamins and essential fatty acids. For the last few decades, pure soyabean oil based LE (S-LE) were used worldwide and consisted of long chain fatty acids with omega 3: omega 6 ratio of 1:5.5. Recently, LE preparations derived from multiple sources have been developed for clinical application. MOFS-LE mixture is one containing a mixture of 30% medium chain triglycerides (MCT), 25% olive oil, 15% fish oil, and 30% soyabean oil. They are supposed to have better immunomodulatory and anti-inflammatory properties with fewer side effects.

There are several studies concerning the comparison between of S-LE and MOFS-LE as regards the efficacy and safety on neonates but without a consensus on the ideal LE .To our knowledge, this is the first randomized controlled trial (RCT) of two different intravenous LE conducted in septic preterm infants to unravel the short term effects of S-LE versus MOFS-LE on the outcomes of neonatal sepsis as well as on the serum levels of sICAM-1 and leukocyte integrin β2. 2. Materials and methods

2.1 Study design and participants Our study is a randomized controlled pilot trial that is conducted in the Neonatal Care Unit (NCU) of Mansoura University Children's Hospital, Egypt including 40 preterm infants. The study was accepted by International research board of Medical Faculty of Mansoura University.