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

N/AUnknownNCT02061150

Hillel Yaffe Medical Center800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Neonatal Sepsis

Eligibility

Sex: ALLMax age: 48 Hours

Medical Language ↔ Plain English

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

Locations (1)

The Hillel Yaffe Medical Center

Hadera, Israel

Outcomes

Primary Outcomes

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

Positive blood cultures out of total cultures

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

Time frame: 3 years

Central Contacts

Amit Hochberg, MD

CONTACT

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

Data from ClinicalTrials.gov

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