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

• Conditions: Neonatal Sepsis

• Registration Number: NCT02061150
• Lead Sponsor: Hillel Yaffe Medical Center

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 available

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12
• Study Start: 2014-03
• Primary Completion: 2015-02
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Positive blood cultures out of total cultures	3 years	Percentage of positive blood cultures out of the total cultures that were taken.

Trial Locations

Locations (1)

The Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel