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NCT Number: NCT06643052

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

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.

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Key information

Conditions

Neonatal Early-onset Sepsis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillel Yaffe medical center

Hadera, 38100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Number of negative blood cultures out of all blood cultures

    Time frame: during first week of life

    Total count of negative blood cultures out of all blood cultures in all patients in group

  2. Number of positive blood cultures

    Time frame: during first week of life

    Total count of positive blood cultures in all patients in group

Secondary outcomes

  1. Cost of treatment

    Time frame: during first week of life

    Total cost of Blood cultures + Blood counts + Antibiotic therpy in all patients in group

Study contacts

Contact information is provided by the study sponsor or research team.

Erez Nadir, MD

CONTACT

[email protected]

+972-4-7744379

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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