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

NCT06643052 | Not Yet Recruiting

• 1 other identifier: 0121-20-HYMC-IL
• Study Type: observational
• Target: 6,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Early-onset Sepsis

Keywords

Neonatal early onset sepsis; Kaiser Permanente calculator

Outcome Measures

Primary Outcomes (2)

• Number of negative blood cultures out of all blood cultures

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

  during first week of life

• Number of positive blood cultures

  Total count of positive blood cultures in all patients in group

  during first week of life

Secondary Outcomes (1)

• Cost of treatment

  during first week of life

Study Arms (2)

Before calculator

Newborn infants before assimilation of EOS calculator

Other: No intervention

With calculator

Newborn infants after assimilation of EOS calculator

Other: No intervention

Interventions

No intervention OTHER

No intervention

Before calculator; With calculator

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants in Hillel Yaffe medical center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe medical center

Hadera, 38100, Israel

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Erez Nadir, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Nadir, MD

CONTACT

+972-4-7744379; erezn@hymc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 15, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

IL (1)