ClinicalTrials.gg
Not yet recruitingNCT06643052Updated Apr 7, 2026

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

An observational study in Neonatal Early-onset Sepsis, sponsored by Hillel Yaffe Medical Center. Not yet recruiting at 1 site in Israel. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Hillel Yaffe Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,300
Ages
Up to 7 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neonatal Early-onset Sepsis

Browse trials for

Keywords

  • Neonatal early onset sepsis
  • Kaiser Permanente calculator
03

In context

Neonatal Sepsis

192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.

This study's planned enrollment of 6,300 is above the median of 200 across 85 observational studies indexed under Neonatal Sepsis.

Browse Neonatal Sepsis studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 305 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newborn infants in Hillel Yaffe medical center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Sepsis workup for other reason
  • 34 weeks of gestation or less
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: during first week of life

  2. Number of positive blood cultures

    Total count of positive blood cultures in all patients in group

    Time frame: during first week of life

Secondary outcomes

  1. Cost of treatment

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

    Time frame: during first week of life

07

Study locations

1 site
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 27940705 ↗

Individual participant data

Plan to share: Undecided — Did not decide yet

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2024
First posted
Oct 15, 2024
StartEst.
Dec 1, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06643052
Responsible party
Erez Nadir, MD (Neonatologist, Hillel Yaffe Medical Center) — Principal investigator
First posted
Oct 15, 2024
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Apr 7, 2026

Study contacts

Erez Nadir, MD
Contact
erezn@hymc.gov.il
+972-4-7744379
Erez Nadir, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion