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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02061150

Enrollment

800

Registered

2014-02-12

Start date

2014-03-31

Completion date

2015-06-30

Last updated

2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis

Keywords

Early onset GBS sepsis, Prevention, Maternal risk factors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 48 Hours

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactAmit Hochberg, MD

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

Outcome results