Management of Infants Born to Group B Streptococcus Positive Mothers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-12-31

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.

Conditions

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Group B Streptococcus Sepsis Infant, Newborn

Keywords

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Group B streptococcus Sepsis Infants Diagnosis Physical examination Laboratory tests

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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IRCCS Burlo Garofolo

Principal Investigators

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Sergio De Marini, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Luigi Cantoni, MD

Role: PRINCIPAL_INVESTIGATOR

San Daniele Hospital, San Daniele, Italy

References

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Cantoni L, Ronfani L, Da Riol R, Demarini S; Perinatal Study Group of the Region Friuli-Venezia Giulia. Physical examination instead of laboratory tests for most infants born to mothers colonized with group B Streptococcus: support for the Centers for Disease Control and Prevention's 2010 recommendations. J Pediatr. 2013 Aug;163(2):568-73. doi: 10.1016/j.jpeds.2013.01.034. Epub 2013 Mar 8.

Reference Type DERIVED

PMID: 23477995 (View on PubMed)

Other Identifiers

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GBS FVG 2004-2006

Identifier Type: -

Identifier Source: org_study_id