- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308526
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study) (PMCNSINICUPS)
October 8, 2017 updated by: Gehad Abdelnaser
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.
Study Overview
Status
Unknown
Conditions
Detailed Description
Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis
was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early
onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neonates from age zero to 28 days
Description
Inclusion Criteria:
- both preterm and full term neonates
- both early onset and late onset neonatal sepsis
Exclusion Criteria:
- Genetic diseases immunocompromized neonates
- Neonates of diabetic mothers
- Neonates of HIV mothers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of neonatal sepsis
Time Frame: From september2017 to september 2018
|
Recognition of prevailing microorganisms causing neonatal sepsis in neonatal intensive care units to take preventive measures against it to decrease the incidence of neonatal sepsis
|
From september2017 to september 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2017
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
October 8, 2017
First Submitted That Met QC Criteria
October 8, 2017
First Posted (Actual)
October 12, 2017
Study Record Updates
Last Update Posted (Actual)
October 12, 2017
Last Update Submitted That Met QC Criteria
October 8, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutUPedia51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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