Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00326313
First received: May 14, 2006
Last updated: May 15, 2006
Last verified: May 2006
  Purpose

Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.

During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.


Condition
Infants With Positive GBS Bacteremia

Study Type: Observational
Official Title: Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 74
Study Start Date: June 2006
Detailed Description:

This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

  • Congenital malformations
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00326313

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Tzipora Strauss, MD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00326313     History of Changes
Other Study ID Numbers: SHEBA-06-4132-TS-CTIL
Study First Received: May 14, 2006
Last Updated: May 15, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Group B streptococci
virulent
morbidity
mortality

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014