Clinical trial NCT04513691: A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
Official title: A Retrospective Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal; Chorioamnionitis, Affecting Fetus
Early-Onset Sepses, Neonatal
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Banner University Medical Center
First posted: 2020-08-14
Enrollment: 236
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: August 28, 2018 through August 28, 2020
measure: 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.
timeFrame: August 28, 2018 through August 28, 2020
measure: 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.
timeFrame: August 28, 2018 through August 28, 2020
Secondary outcomes:
measure: To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.
timeFrame: August 28, 2018 through August 28, 2020
measure: To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.
timeFrame: August 28, 2018 through August 28, 2020
measure: To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.
timeFrame: August 28, 2018 through August 28, 2020
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
Study officials:
References: