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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06643052
Enrollment
6300
Registered
2024-10-15
Start date
2026-12-01
Completion date
2027-12-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Early-onset Sepsis

Keywords

Neonatal early onset sepsis, Kaiser Permanente calculator

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of negative blood cultures out of all blood culturesduring first week of lifeTotal count of negative blood cultures out of all blood cultures in all patients in group
Number of positive blood culturesduring first week of lifeTotal count of positive blood cultures in all patients in group

Secondary

MeasureTime frameDescription
Cost of treatmentduring first week of lifeTotal cost of Blood cultures + Blood counts + Antibiotic therpy in all patients in group

Countries

Israel

Contacts

CONTACTErez Nadir, MD
erezn@hymc.gov.il+972-4-7744379
PRINCIPAL_INVESTIGATORErez Nadir, MD

Hillel Yaffe Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026