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

May 15, 2006 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment

74

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

  • Congenital malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Tzipora Strauss, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

May 14, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (ESTIMATE)

May 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2006

Last Update Submitted That Met QC Criteria

May 15, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-06-4132-TS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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