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

NCT06643052 — Not yet recruiting, 6300 participants, Hillel Yaffe Medical Center

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RegistryNCT06643052
StatusNot yet recruiting
Study typeObservational
Enrollment6300 (Estimated)
SponsorHillel Yaffe Medical Center (Other gov)
ConditionsNeonatal Early-onset Sepsis
InterventionsNo intervention (Other)
Datesstart 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
Locations1 site in Israel

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Before calculatorOther: No interventionNewborn infants before assimilation of EOS calculator
With calculatorOther: No interventionNewborn infants after assimilation of EOS calculator
  • No intervention (Other): No intervention

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Cost of treatment [during first week of life]: Total cost of Blood cultures + Blood counts + Antibiotic therpy in all patients in group

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Hillel Yaffe medical centerHaderaIsrael

+Publications

  • Kuzniewicz MW, Puopolo KM, Fischer A, Walsh EM, Li S, Newman TB, Kipnis P, Escobar GJ. A Quantitative, Risk-Based Approach to the Management of Neonatal Early-Onset Sepsis. JAMA Pediatr. 2017 Apr 1;171(4):365-371. doi: 10.1001/jamapediatrics.2016.4678. PMID 28241253
  • Hochberg A, Yehezkeli V, Nadir E, Foldi S, Feldman M. [INFECTIOUS DISEASE ASSESSMENT OF TERM INFANTS WITH RISK FACTORS - EVALUATION OF NECESSITY AND METHODS OF PREVENTION]. Harefuah. 2019 Jan;158(1):25-29. Hebrew. PMID 30663289
  • Nanduri SA, Petit S, Smelser C, Apostol M, Alden NB, Harrison LH, Lynfield R, Vagnone PS, Burzlaff K, Spina NL, Dufort EM, Schaffner W, Thomas AR, Farley MM, Jain JH, Pondo T, McGee L, Beall BW, Schrag SJ. Epidemiology of Invasive Early-Onset and Late-Onset Group B Streptococcal Disease in the United States, 2006 to 2015: Multistate Laboratory and Population-Based Surveillance. JAMA Pediatr. 2019 Mar 1;173(3):224-233. doi: 10.1001/jamapediatrics.2018.4826. PMID 30640366
  • Weston EJ, Pondo T, Lewis MM, Martell-Cleary P, Morin C, Jewell B, Daily P, Apostol M, Petit S, Farley M, Lynfield R, Reingold A, Hansen NI, Stoll BJ, Shane AL, Zell E, Schrag SJ. The burden of invasive early-onset neonatal sepsis in the United States, 2005-2008. Pediatr Infect Dis J. 2011 Nov;30(11):937-41. doi: 10.1097/INF.0b013e318223bad2. PMID 21654548
  • Schrag SJ, Farley MM, Petit S, Reingold A, Weston EJ, Pondo T, Hudson Jain J, Lynfield R. Epidemiology of Invasive Early-Onset Neonatal Sepsis, 2005 to 2014. Pediatrics. 2016 Dec;138(6):e20162013. doi: 10.1542/peds.2016-2013. PMID 27940705

+Investigators

My Notes