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NCT00716781 Clinical Trial

Management of Infants Born to Group B Streptococcus Positive Mothers.

Sepsis Clinical Trial

Official title:
Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00716781
Other study ID # GBS FVG 2004-2006
Secondary ID
Status Completed
Phase N/A
First received July 14, 2008
Last updated July 14, 2008
Start date July 2004
Est. completion date December 2006

Study information
Verified date July 2008
Source IRCCS Burlo Garofolo
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset neonatal sepsis caused by GBS. According to current recommendations, the evaluation of infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential, a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the evaluation process is not firmly established.

Description:

After implementation of appropriate guidelines, early-onset GBS sepsis has become a low incidence disease (CDC). Recent rates are as low as 0.34 cases /1000 live births. According to CDC recommendations, the evaluation of infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential, a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the evaluation process is not firmly established. There are several reviews on the predictive value of CBC and putative markers of early onset neonatal sepsis, but there seems to be no ideal laboratory test to assist the clinician in the diagnosis (Fowlie 1998, Malik 2003, Ottolini 2003). Given the continuing concerns about the reliability of laboratory tests, one may ask the question of whether physical examination might be at least as good as haematological indices. We are not aware of studies assessing the value of physical examination vs CBC, in the evaluation of asymptomatic at risk newborns.

The aim of this study was to compare two approaches in the management of infants at risk for GBS sepsis: laboratory tests (CBC, differential and BC) with observation vs clinical observation alone.

Recruitment information / eligibility
Status Completed
Enrollment 16394
Est. completion date December 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All newborns born in Friuli Venezia Giulia Region (Italy)

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
IRCCS Burlo Garofolo Friuli Venezia Giulia Regional Health Authority

Outcome
Type Measure Description Time frame Safety issue
Primary Number of infants treated with antibiotics Study period No
Secondary Time elapsed from the onset of symptoms to the beginning of antibiotic treatment Study period No
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