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

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ClinicalTrials.gov Identifier: NCT02061150
Recruitment Status : Unknown
Verified February 2014 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease
Neonatal Sepsis

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : March 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
Asymptomatic newborns that had sepsis workup
Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.



Primary Outcome Measures :
  1. Asymptomatic newborns that underwent sepsis workup [ Time Frame: 3 years ]
    The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined


Secondary Outcome Measures :
  1. Positive blood cultures out of total cultures [ Time Frame: 3 years ]
    Percentage of positive blood cultures out of the total cultures that were taken.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061150


Contacts
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Contact: Amit Hochberg, MD +972-4-6304320 amith@hy.health.gov.il

Locations
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Israel
The Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Amit Hochberg, MD    +972-4-6304320    amith@hy.health.gov.il   
Principal Investigator: Amit Hochberg, MD         
Sub-Investigator: Michael Feldman, MD         
Sub-Investigator: Erez Nadir, MD         
Sub-Investigator: Sylvia Foldi, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02061150     History of Changes
Other Study ID Numbers: HYMC-104-13
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Hillel Yaffe Medical Center:
Early onset GBS sepsis
Prevention
Maternal risk factors

Additional relevant MeSH terms:
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Sepsis
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases