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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University Children Hospital
• Treatments: Fat Emulsions, Intravenous; SMOFlipid

Criteria

Inclusion Criteria:

• Gestational age of 28 to less than 37 weeks who showed clinical symptoms and signs suggestive of early-onset sepsis (EOS, within 72 hours of birth) or late-onset sepsis (LOS, after 72 hours of birth) and received PN.

Exclusion Criteria: Neonates with

• Major congenital malformations

• Congenital heart diseases

• Inborn errors of metabolism

• Congenital infections

• Hypoxic-ischemic encephalopathy