Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent

Neonatal Sepsis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02061150
• Other study ID #: HYMC-104-13
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 11, 2014
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2014
• Source: Hillel Yaffe Medical Center
• Contact: Amit Hochberg, MD
• Phone: +972-4-6304320
• Email: amith[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

Inclusion Criteria:

Term newborns with blood cultures taken from them the first 48 hrs

Exclusion Criteria:

• Preterm newborns

• Septic/ill appearing newborns

• Newborns requiring admission to NICU

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis

Locations

Country	Name	City	State
Israel	The Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymptomatic newborns that underwent sepsis workup	The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined	3 years	No
Secondary	Positive blood cultures out of total cultures	Percentage of positive blood cultures out of the total cultures that were taken.	3 years	No