| Registry | NCT06643052 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 6300 (Estimated) |
| Sponsor | Hillel Yaffe Medical Center (Other gov) |
| Conditions | Neonatal Early-onset Sepsis |
| Interventions | No intervention (Other) |
| Dates | start 2026-12-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-12-01 (estimated), first posted 2024-10-15, last updated 2026-04-07 |
| Locations | 1 site in Israel |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Before calculator | Other: No intervention | Newborn infants before assimilation of EOS calculator | |
| With calculator | Other: No intervention | Newborn infants after assimilation of EOS calculator |
Sex: All, ages: any to 7 Days
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hillel Yaffe medical center | Hadera | Israel |