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
1 other identifier
observational
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedNovember 22, 2022
September 1, 2022
1.9 years
August 6, 2020
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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.
To determine the usage of EOS Calculator measuring decreased antibiotic usage.
August 28, 2018 through August 28, 2020
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.
To determine the usage of EOS Calculator measuring laboratory testing.
August 28, 2018 through August 28, 2020
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.
To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns
August 28, 2018 through August 28, 2020
Secondary Outcomes (3)
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, 2020
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, 2020
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, 2020
Study Arms (1)
Sample
Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.
Interventions
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
Eligibility Criteria
Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix April 28, 2018 through April 28, 2020 whose mothers were determined or suspected to have CAM.
You may qualify if:
- Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.
You may not qualify if:
- Direct NICU Admissions
- Subjects may be excluded at Investigator discretion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pediatrixlead
- Banner University Medical Centercollaborator
Study Sites (1)
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 14, 2020
Study Start
September 30, 2020
Primary Completion
August 10, 2022
Study Completion
August 10, 2022
Last Updated
November 22, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share