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Management of Infants Born to Group B Streptococcus Positive Mothers.

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ClinicalTrials.gov Identifier: NCT00716781
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : July 16, 2008
Sponsor:
Collaborator:
Friuli Venezia Giulia Regional Health Authority
Information provided by:
IRCCS Burlo Garofolo

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.

Condition or disease
Group B Streptococcus Sepsis Infant, Newborn

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
Actual Enrollment : 16394 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination
Study Start Date : July 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Number of infants treated with antibiotics [ Time Frame: Study period ]

Secondary Outcome Measures :
  1. Time elapsed from the onset of symptoms to the beginning of antibiotic treatment [ Time Frame: Study period ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newborns born in Friuli Venezia Giulia Region (Italy) during the study period
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716781


Sponsors and Collaborators
IRCCS Burlo Garofolo
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sergio De Marini, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00716781     History of Changes
Other Study ID Numbers: GBS FVG 2004-2006
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: July 2008

Keywords provided by IRCCS Burlo Garofolo:
Group B streptococcus
Sepsis
Infants
Diagnosis
Physical examination
Laboratory tests

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes