CClinicalTrials.gg
Status unknownNCT02061150Updated Feb 12, 2014

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

An observational study in Neonatal Sepsis, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2014-02-12.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
800
Ages
Up to 48 Hours
Sex
All
01

Study 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.

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Conditions studied

  • Neonatal Sepsis

Keywords

  • Early onset GBS sepsis
  • Prevention
  • Maternal risk factors
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 800 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 48 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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,

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Preterm newborns
  • Septic/ill appearing newborns
  • Newborns requiring admission to NICU
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Asymptomatic newborns that had sepsis workup

    Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.

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What researchers measure

Primary outcomes

  1. Asymptomatic newborns that underwent sepsis workup

    The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined

    Time frame: 3 years

Secondary outcomes

  1. Positive blood cultures out of total cultures

    Percentage of positive blood cultures out of the total cultures that were taken.

    Time frame: 3 years

07

Study locations

1 site
  • The Hillel Yaffe Medical Center
    Hadera, 38100, Israel
    • Amit Hochberg, MD · Contact · amith@hy.health.gov.il · +972-4-6304320
    • Amit Hochberg, MD · Principal investigator
    • Michael Feldman, MD · Sub investigator
    • Erez Nadir, MD · Sub investigator
    • Sylvia Foldi, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02061150
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Feb 12, 2014
Start date
Mar 2014
Primary completion
Feb 2015 (estimated)
Completion
Jun 2015 (estimated)
Last update
Feb 12, 2014

Study contacts

Amit Hochberg, MD
Contact
amith@hy.health.gov.il
+972-4-6304320

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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