Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis Calculator

Not yet recruiting

• Conditions: Neonatal Early-onset Sepsis

• Registration Number: NCT06643052
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

Early neonatal sepsis requires rapid and efficient intervention to prevent morbidity and mortality. Management of such a case includes invasive blood examinations, elongation of maternal and neonatal length of stay, and empiric antibiotic therapy. These actions has major side effects. On 2017, Kaiser-Permanente started using a calculator that weighs the chances for early onset neonatal sepsis, and states the best investigation and follow-up regimn for the specific newborn infant. Eversince, policy of managing neonatal suspected early onset sepsis has chaged globally, including in Israel. Current knowledge regarding the local outcome since the use of the calculatir is scarce.

The goal of the study is to evaluate the change in management of suspected neonatal early onset sepsis, including its economic value, between periods before and after assimilation of the calculator in Hillel Yaffe nedica l center.

Detailed Description

Early neonatal sepsis requires rapid and efficient intervention to prevent morbidity and mortality. Management of such a case includes invasive blood examinations, elongation of maternal and neonatal length of stay, and empiric antibiotic therapy. These actions has major side effects. On 2017, Kaiser-Permanente started using a calculator that weighs the chances for early onset neonatal sepsis, and states the best investigation and follow-up regimn for the specific newborn infant. Eversince, policy of managing neonatal suspected early onset sepsis has chaged globally, including in Israel. Current knowledge regarding the local outcome since the use of the calculatir is scarce.

The goal of the study is to evaluate the change in management of suspected neonatal early onset sepsis, including its economic value, between periods before and after assimilation of the calculator in Hillel Yaffe nedical center.

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Study Start: 2025-12-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6300

Inclusion Criteria

• Newborn unfants born in Hillel Yaffe medical center
• 35 weeks of gestation or more
• Blood culture was taken

Exclusion Criteria

• Sepsis workup for other reason
• 34 weeks of gestation or less

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of negative blood cultures out of all blood cultures	during first week of life	Total count of negative blood cultures out of all blood cultures in all patients in group
Number of positive blood cultures	during first week of life	Total count of positive blood cultures in all patients in group

Secondary Outcome Measures

Name	Time	Method
Cost of treatment	during first week of life	Total cost of Blood cultures + Blood counts + Antibiotic therpy in all patients in group

Trial Locations

Locations (1)

Hillel Yaffe medical center; 🇮🇱 Hadera, Israel