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NCT04513691 · ClinicalTrials.gov registry record
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
A clinical trial, sponsored by Pediatrix.
- Completed
- Registry status
- 236
- Enrollment target
NCT04513691: Completed study, sponsored by Pediatrix.
NCT04513691 is a clinical trial that has completed, run by Pediatrix. The registered enrollment target is 236 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04513691 has completed, sponsored by Pediatrix.
- COMPLETED
- Registry status
- 236 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the usage of EOS Calculator measuring decreased antibiotic usage.
Interventions
- DIAGNOSTIC_TEST EOS Calculator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2022-08-10 |
What the finished NCT04513691 record still lists
NCT04513691 is an observational study that tracks outcomes without assigning an intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which EOS Calculator is the first listed.
NCT04513691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04513691 about?
NCT04513691 is a clinical study titled "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 ges...
What is the current status of trial NCT04513691?
This trial is currently completed. The enrollment target is 236 participants. The study started on 2020-09-30. Estimated completion is 2022-08-10.
What interventions are being tested in trial NCT04513691?
The interventions under investigation include: EOS Calculator (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04513691?
This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.
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