NCT02061150

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.

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

February 11, 2014

Last Update Submit

February 11, 2014

Conditions

Neonatal Sepsis

Keywords

Early onset GBS sepsisPreventionMaternal risk factors

Outcome Measures

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

    3 years

Secondary Outcomes (1)

  • Positive blood cultures out of total cultures

    3 years

Study Arms (1)

Asymptomatic newborns that had sepsis workup

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

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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,

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Amit Hochberg, MD

CONTACT

+972-4-6304320amith@hy.health.gov.il

Study Design

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

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

IL(1)