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| Sponsors and Collaborators: |
IRCCS Burlo Garofolo Friuli Venezia Giulia Regional Health Authority |
|---|---|
| Information provided by: | IRCCS Burlo Garofolo |
| ClinicalTrials.gov Identifier: | NCT00716781 |
Purpose
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.
| Condition |
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Group B Streptococcus Sepsis Infant, Newborn |
| Study Type: | Observational |
| Study Design: | Ecologic or Community, Prospective |
| Official Title: | Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination |
| Enrollment: | 16394 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1 (first year)
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
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2 (second year)
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)
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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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All newborns born in Friuli Venezia Giulia Region (Italy) during the study period
Inclusion Criteria:
Contacts and Locations| Study Chair: | Sergio De Marini, MD | IRCCS Burlo Garofolo, Trieste, Italy |
| Principal Investigator: | Luigi Cantoni, MD | San Daniele Hospital, San Daniele, Italy |
More Information
| Responsible Party: | IRCCS Burlo Garofolo ( Sergio De Marini ) |
| Study ID Numbers: | GBS FVG 2004-2006 |
| Study First Received: | July 14, 2008 |
| Last Updated: | July 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00716781 |
| Health Authority: | Italy: Ministry of Health |
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Group B streptococcus Sepsis Infants |
Diagnosis Physical examination Laboratory tests |
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Systemic Inflammatory Response Syndrome Sepsis Inflammation |
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Pathologic Processes Infection |
