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A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator

A Retrospective Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04513691
Enrollment
236
Registered
2020-08-14
Start date
2020-09-30
Completion date
2022-08-10
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Onset Sepses, Neonatal, Maternal; Chorioamnionitis, Affecting Fetus

Brief summary

This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Newborns enrolled will be at least 35 weeks gestational age (GA) and have a maternal diagnosis of at least suspected or confirmed CAM. The data will include those newborns whose assessment and treatment were not guided by the EOS calculator which was implemented on August 28, 2019 and those with which the EOS calculator was utilized. A secondary objective is to show the economic impact with utilization of the EOS calculator. Data collected will include full laboratory workups including complete blood counts (CBC), blood cultures, antibiotic usage, length of time in the newborn nursery and total length of stay.

Interventions

DIAGNOSTIC_TESTEOS Calculator

Neonatal Early-Onset Sepsis Risk Calculator which is a tool that determines the risk of EOS for a particular newborn by looking at maternal risk factors and the newborn's clinical picture as opposed to just laboratory tests alone

Sponsors

Banner University Medical Center
CollaboratorOTHER
Pediatrix
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

* Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.

Exclusion criteria

* Direct NICU Admissions * Subjects may be excluded at Investigator discretion

Design outcomes

Primary

MeasureTime frameDescription
To determine whether the usage of Neonatal EOS Calculator decreased antibiotic usage in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.August 28, 2018 through August 28, 2020To determine the usage of EOS Calculator measuring decreased antibiotic usage.
To determine whether the usage of Neonatal EOS Calculator measuring laboratory testing in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.August 28, 2018 through August 28, 2020To determine the usage of EOS Calculator measuring laboratory testing.
To determine whether the usage of Neonatal EOS Calculator LOS in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.August 28, 2018 through August 28, 2020To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns

Secondary

MeasureTime frameDescription
To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.August 28, 2018 through August 28, 2020Evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage.
To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.August 28, 2018 through August 28, 2020Evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests.
To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.August 28, 2018 through August 28, 2020Evaluate the economic impact after the implementation of the EOS Calculator LOS in newborn nursery and total length of hospital stay.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026