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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00326313
Other study ID # SHEBA-06-4132-TS-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 14, 2006
Last updated May 15, 2006
Start date June 2006

Study information

Verified date May 2006
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Weeks
Eligibility Inclusion Criteria:

- GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

- Congenital malformations

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center