Neonatal Sepsis Workup for High Risk Newborns - Evaluatio... | NCT02061150

Studies
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent

NCT02061150

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Feb 12, 2014Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Neonatal Sepsis

Interventions

Not provided

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

Feb 2014

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 2014

Primary Completion Date

Feb 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Feb 11, 2014

First Submission Date that Met QC Criteria

Feb 11, 2014

First Posted Date

Feb 12, 2014Estimated

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

Feb 11, 2014

Last Update Posted Date

Feb 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.

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

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asymptomatic newborns that had sepsis workup		Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asymptomatic newborns that underwent sepsis workup	The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined	3 years

Secondary Outcomes

Measure	Description	Time Frame
Positive blood cultures out of total cultures	Percentage of positive blood cultures out of the total cultures that were taken.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term newborns with blood cultures taken from them the first 48 hrs

Exclusion Criteria:

Preterm newborns
Septic/ill appearing newborns
Newborns requiring admission to NICU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

48 Hours

Standard Ages

Child

Study Population

Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amit Hochberg, MD	Contact	+972-4-6304320		amith@hy.health.gov.il

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D000071074	Neonatal Sepsis

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided