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

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 Overview

• Status: Unknown
• Conditions: Neonatal Sepsis

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Amit Hochberg, MD; Phone Number: +972-4-6304320; Email: amith@hy.health.gov.il

Study Locations

• Israel
  • Hadera, Israel, 38100
    • The Hillel Yaffe Medical Center
    • Contact: Amit Hochberg, MD; Phone Number: +972-4-6304320; Email: amith@hy.health.gov.il
    • Sub-Investigator: Erez Nadir, MD
    • Sub-Investigator: Sylvia Foldi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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,

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Asymptomatic newborns that had sepsis workup; Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ANTICIPATED): February 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (ESTIMATE): February 12, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Prevention; Early onset GBS sepsis; Maternal risk factors
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis
• Other Study ID Numbers: HYMC-104-13