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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03275090 |
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Date of registration:
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04/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis
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Scientific title:
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The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis: a Randomized Pilot Controlled Trial |
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Date of first enrolment:
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February 1, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03275090 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Yahya M Wahba, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University Children Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
28 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sepsis Newborn
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Intervention(s)
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Drug: Smoflipid ®
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Primary Outcome(s)
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levels of soluble intercellular adhesion molecule 1 (sICAM-1)
[Time Frame: "first day of randomization and 7th days"]
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leukocyte integrin ß2 Level
[Time Frame: "first day of randomization and 7th days"]
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Secondary Outcome(s)
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duration of hospital stay
[Time Frame: "through study completion, an average of 12 months"]
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Duration of mechanical ventilation
[Time Frame: "through study completion, an average of 12 months"]
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Mortality rate
[Time Frame: "through study completion, an average of 12 months"]
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Duration of antibiotic treatment
[Time Frame: "through study completion, an average of 12 months"]
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Secondary ID(s)
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MansouraUCH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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