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

Completed

• Conditions: Maternal; Chorioamnionitis, Affecting Fetus; Early-Onset Sepses, Neonatal
• Interventions: Diagnostic Test: EOS Calculator

• Registration Number: NCT04513691
• Lead Sponsor: Pediatrix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2020-09-30
• Primary Completion: 2022-08-10
• Study Completion: 2022-08-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sample	EOS Calculator	Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.

Primary Outcome Measures

Name	Time	Method
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, 2020	To determine the usage of EOS Calculator measuring laboratory testing.
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, 2020	To determine the usage of EOS Calculator measuring decreased antibiotic usage.
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, 2020	To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns

Secondary Outcome Measures

Name	Time	Method
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	Evaluate 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, 2020	Evaluate the economic impact after the implementation of the EOS Calculator LOS in newborn nursery and total length of hospital stay.
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	Evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage.

Trial Locations

Locations (1)

Banner - University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States