Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513691
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2020-08-06
Brief Title:
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
Sponsor:
Pediatrix
Organization:
Pediatrix
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None