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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
Sponsor:
Information provided by (Responsible Party):
Yahya Wahba, Mansoura University Children Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Sepsis Newborn Drug: Smoflipid ® Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: SMOFlipid

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Egypt
Mansoura University Children Hospital
Mansourah, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University Children Hospital
Investigators
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Principal Investigator: Yahya M Wahba, MD Mansoura University Children Hospital

Publications of Results:

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Responsible Party: Yahya Wahba, Principal Investigator, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03275090     History of Changes
Other Study ID Numbers: MansouraUCH
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yahya Wahba, Mansoura University Children Hospital:
lipid emulsions; preterm; sepsis

Additional relevant MeSH terms:
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Infant, Newborn, Diseases
Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions