Management of Infants Born to Group B Streptococcus Positive Mothers.

Completed

• Conditions: Group B Streptococcus; Sepsis; Infant, Newborn

• Registration Number: NCT00716781
• Lead Sponsor: IRCCS Burlo Garofolo

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2006-06
• Study Completion: 2006-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Last Update Submitted: 2008-07-14
• Study First Posted: 2008-07-16
• Last Update Posted: 2008-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16394

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of infants treated with antibiotics	Study period

Secondary Outcome Measures

Name	Time	Method
Time elapsed from the onset of symptoms to the beginning of antibiotic treatment	Study period