Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Identification of Pathogens in the Neonatal Intensive Care Unit (NICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077100
Recruitment Status : Unknown
Verified March 2017 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Tracking Information
First Submitted Date March 1, 2017
First Posted Date March 10, 2017
Last Update Posted Date March 10, 2017
Estimated Study Start Date March 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2017)
Antibiogram [ Time Frame: One year ]
Positive cultures will be examined using an antibiogram and pathogens will be identified
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Pathogens in the Neonatal Intensive Care Unit (NICU)
Official Title Identification of Pathogens and Their Antibiogram in the Neonatal Intensive Care Unit (NICU)
Brief Summary To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Newborns hospitalized in NICU with positive cultures
Condition Pathogen Resistance
Intervention Other: Laboratory identification of positive cultures
Laboratory identification of positive cultures
Study Groups/Cohorts Newborns with positive cultures
Positive cultures of newborns hospitalized in the NICU in the past 5 years will undergo laboratory examination and identification
Intervention: Other: Laboratory identification of positive cultures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 6, 2017)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newborns with positive cultures

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03077100
Other Study ID Numbers HYMC-0001-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hillel Yaffe Medical Center
Study Sponsor Hillel Yaffe Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Michael Feldman, MD Hillel Yaffe Medical Center
PRS Account Hillel Yaffe Medical Center
Verification Date March 2017