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

NCT ID: NCT04513691

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-08-10

Brief Summary

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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

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Conditions

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Maternal; Chorioamnionitis, Affecting Fetus Early-Onset Sepses, Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sample

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

EOS Calculator

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Banner University Medical Center

OTHER

Sponsor Role collaborator

Pediatrix

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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641575377

Identifier Type: -

Identifier Source: org_study_id

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