The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis
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|ClinicalTrials.gov Identifier: NCT03275090|
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : March 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Newborn||Drug: Smoflipid ®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis: a Randomized Pilot Controlled Trial|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||January 2, 2017|
|Actual Study Completion Date :||February 1, 2017|
Active Comparator: Intralipid injectable product (MOFS)
20 preterm infants receive parenteral nutrition containing 20% MOFS lipid emulsion (Smoflipid ®)
Drug: Smoflipid ®
Other Name: MOFS lipid emulsion
No Intervention: Pure Soybean oil lipid emulsion
20 preterm infants with sepsis receive the usual parenteral nutrition containing soybean oil based lipid emulsion (20% Intralipid ®) at daily increasing doses guided by serum triglycerides.
- levels of soluble intercellular adhesion molecule 1 (sICAM-1) [ Time Frame: "first day of randomization and 7th days" ]changes in levels of sICAM-1 in septic preterm infants after receiving one of the two different lipid emulsions for seven days.
- leukocyte integrin ß2 Level [ Time Frame: "first day of randomization and 7th days" ]changes in leukocyte integrin ß2 level in septic preterm infants after receiving one of the two different lipid emulsions for seven days.
- duration of hospital stay [ Time Frame: "through study completion, an average of 12 months" ]Effect of two different lipid emulsions on hospital stay duration in septic preterm infants
- Duration of antibiotic treatment [ Time Frame: "through study completion, an average of 12 months" ]Effect of two different lipid emulsions on duration of antibiotics treatment in septic preterm infants
- Duration of mechanical ventilation [ Time Frame: "through study completion, an average of 12 months" ]Effect of two different lipid emulsions on duration of mechanical ventilation in septic preterm infants
- Mortality rate [ Time Frame: "through study completion, an average of 12 months" ]Effect of two different lipid emulsions on mortality rate in septic preterm infants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275090
|Mansoura University Children Hospital|
|Mansourah, Dakahlia, Egypt, 35516|
|Principal Investigator:||Yahya M Wahba, MD||Mansoura University Children Hospital|