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Completed

NCT Number: NCT04513691

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

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.

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Key information

Conditions

Maternal; Chorioamnionitis, Affecting Fetus Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Early-Onset Sepses, Neonatal Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Pregnancy Complications Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

35 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS Calculator

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

Primary outcomes

  1. 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.

    Time frame: August 28, 2018 through August 28, 2020

    To determine the usage of EOS Calculator measuring decreased antibiotic usage.

  2. 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.

    Time frame: August 28, 2018 through August 28, 2020

    To determine the usage of EOS Calculator measuring laboratory testing.

  3. 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.

    Time frame: August 28, 2018 through August 28, 2020

    To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns

Secondary outcomes

  1. To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.

    Time frame: August 28, 2018 through August 28, 2020

    Evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage.

  2. To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.

    Time frame: August 28, 2018 through August 28, 2020

    Evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests.

  3. To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

  • Banner University Medical Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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