Identification of Pathogens in the Neonatal Intensive Car... | NCT03077100

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

NCT03077100

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 10, 2017Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Pathogen Resistance

Interventions

Laboratory identification of positive cultures

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2017Estimated

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Mar 1, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laboratory identification of positive cultures	Other	Laboratory identification of positive cultures	Newborns with positive cultures

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newborns with positive cultures

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Newborns hospitalized in NICU with positive cultures

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samah Abu-Fanni, MD	Contact			samah_af88@hotmail.com

Overall Officials

Name	Affiliation	Role
Michael Feldman, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided