An observational study in Maternal; Chorioamnionitis, Affecting Fetus and Early-Onset Sepses, Neonatal, sponsored by Pediatrix. Completed at 1 site in United States. Open to participants aged 35 Weeks and older. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by Pediatrix · Observational
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's enrollment of 236 is above the median of 125 across 14 observational studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.
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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.
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Exclusion Criteria:
Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.
Diagnostic Test: EOS 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
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.
Time frame: 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.
Time frame: 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
Time frame: August 28, 2018 through August 28, 2020
To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.
Evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage.
Time frame: 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.
Evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests.
Time frame: 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.
Evaluate the economic impact after the implementation of the EOS Calculator LOS in newborn nursery and total length of hospital stay.
Time frame: August 28, 2018 through August 28, 2020
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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