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Management of Infants Born to Group B Streptococcus Positive Mothers.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00716781
Enrollment
16394
Registered
2008-07-16
Start date
2004-07-31
Completion date
2006-12-31
Last updated
2008-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group B Streptococcus, Infant, Newborn, Sepsis

Keywords

Group B streptococcus, Sepsis, Infants, Diagnosis, Physical examination, Laboratory tests

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.

Interventions

None listed

Sponsors

Friuli Venezia Giulia Regional Health Authority
CollaboratorUNKNOWN
IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Number of infants treated with antibioticsStudy period

Secondary

MeasureTime frame
Time elapsed from the onset of symptoms to the beginning of antibiotic treatmentStudy period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026