NCT03077100

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 1, 2017

Last Update Submit

March 6, 2017

Conditions

Pathogen Resistance

Outcome Measures

Primary Outcomes (1)

  • Antibiogram

    Positive cultures will be examined using an antibiogram and pathogens will be identified

    One year

Study Arms (1)

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

Interventions

Laboratory identification of positive culturesOTHER

Laboratory identification of positive cultures

Newborns with positive cultures

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborns hospitalized in NICU with positive cultures

You may qualify if:

  • Newborns with positive cultures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Michael Feldman, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samah Abu-Fanni, MD

CONTACT

samah_af88@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 10, 2017

Study Start

March 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)