Management of Infants Born to Group B Streptococcus Positive Mothers.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Group B Streptococcus, Sepsis, Infant, Newborn

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newborns born in Friuli Venezia Giulia Region (Italy)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 (first year)<br>Asymptomatic infants born to GBS-positive mothers or to mothers with risk factors and incomplete prophylaxis were managed according to the CDC protocol. Blood cultures and CBC were performed and the infant was observed for 48 hours. Participating hospital were free to perform any additional test, such as CRP, MiniESR, etc | |
| 2 (second year)<br>Asymptomatic infants born to GBS-positive mothers or to mothers with risk factors and incomplete prophylaxis were managed with clinical observation only. Clinical surveillance was based on 3 signs: 1. Skin appearance (pink, pale, mottled, cyanotic); 2. Respiratory rate (>50 or <50 breaths per minute); 3. Dyspnea (Yes / No) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants treated with antibiotics |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time elapsed from the onset of symptoms to the beginning of antibiotic treatment |  | Study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group B streptococcus, Sepsis, Infants, Diagnosis, Physical examination, Laboratory tests