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

Early-Onset Sepses, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513691
• Other study ID #: 641575377
• Status: Completed
• Start date: September 30, 2020
• Est. completion date: August 10, 2022

Study information

• Verified date: September 2022
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Chorioamnionitis
• Early-Onset Sepses, Neonatal
• Maternal; Chorioamnionitis, Affecting Fetus
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety	Banner University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	August 28, 2018 through August 28, 2020
Secondary	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.	August 28, 2018 through August 28, 2020
Secondary	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.	August 28, 2018 through August 28, 2020