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

March 6, 2017 updated by: Hillel Yaffe Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

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 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborns hospitalized in NICU with positive cultures

Description

Inclusion Criteria:

  • Newborns with positive cultures

Exclusion Criteria:

-

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newborns with positive cultures
Positive cultures of newborns hospitalized in the NICU in the past 5 years will undergo laboratory examination and identification
Other: Laboratory identification of positive cultures
Laboratory identification of positive cultures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiogram
Time Frame: One year
Positive cultures will be examined using an antibiogram and pathogens will be identified
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Michael Feldman, MD, Hillel Yaffe Medical Center

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)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HYMC-0001-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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