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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326313
First Posted: May 16, 2006
Last Update Posted: May 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

  • Congenital malformations
  Contacts and Locations
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): NCT00326313


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

ClinicalTrials.gov Identifier: NCT00326313     History of Changes
Other Study ID Numbers: SHEBA-06-4132-TS-CTIL
First Submitted: May 14, 2006
First Posted: May 16, 2006
Last Update Posted: May 16, 2006
Last Verified: May 2006

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