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Management of Infants Born to Group B Streptococcus Positive Mothers.

This study has been completed.
Sponsor:
Collaborator:
Friuli Venezia Giulia Regional Health Authority
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00716781
First received: July 14, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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
Group B Streptococcus
Sepsis
Infant, Newborn

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Number of infants treated with antibiotics [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time elapsed from the onset of symptoms to the beginning of antibiotic treatment [ Time Frame: Study period ] [ Designated as safety issue: No ]

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
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)

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

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sergio De Marini, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00716781     History of Changes
Other Study ID Numbers: GBS FVG 2004-2006
Study First Received: July 14, 2008
Last Updated: July 14, 2008
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013