Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02061150
Status:
UNKNOWN
Last Update Posted:
2014-02-12
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Sponsor:
Hillel Yaffe Medical Center
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
NOT_YET_RECRUITING
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:
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: