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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Infant, Newborn; Group B Streptococcus

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.

• Study Type: Observational
• Enrollment (Actual): 16394

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All newborns born in Friuli Venezia Giulia Region (Italy) during the study period

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Collaborators: Friuli Venezia Giulia Regional Health Authority
• Investigators: Study Chair: Sergio De Marini, MD, IRCCS Burlo Garofolo, Trieste, Italy; Principal Investigator: Luigi Cantoni, MD, San Daniele Hospital, San Daniele, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 16, 2008
• Last Update Submitted That Met QC Criteria: July 14, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Diagnosis; Sepsis; Infants; Group B streptococcus; Physical examination; Laboratory tests
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: GBS FVG 2004-2006