Sepsis Clinical Trial
Official title:
Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination
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.
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.
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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