Clinical trial NCT00716781: Management of Infants Born to Group B Streptococcus Positive Mothers.
Official title: Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group B Streptococcus
Sepsis
Infant, Newborn
Keywords: Group B streptococcus
Sepsis
Infants
Diagnosis
Physical examination
Laboratory tests
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
Collaborators: name: Friuli Venezia Giulia Regional Health Authority
First posted: 2008-07-16
Enrollment: 16394
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns born in Friuli Venezia Giulia Region (Italy) during the study period

Brief summary: 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: 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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Number of infants treated with antibiotics
timeFrame: Study period
Secondary outcomes:
measure: Time elapsed from the onset of symptoms to the beginning of antibiotic treatment
timeFrame: Study period
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Sergio De Marini, MD
role: STUDY_CHAIR
affiliation: San Daniele Hospital, San Daniele, Italy
name: Luigi Cantoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.