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

NCT ID: NCT02061150

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Neonatal Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Asymptomatic newborns that had sepsis workup

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

No interventions assigned to this group

Eligibility Criteria

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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Hillel Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Central Contacts

Amit Hochberg, MD

Role: CONTACT

amith@hy.health.gov.il

+972-4-6304320

Facility Contacts

Amit Hochberg, MD

Role: primary

amith@hy.health.gov.il

+972-4-6304320

Other Identifiers

HYMC-104-13

Identifier Type: -

Identifier Source: org_study_id