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
|Condition or disease|
|Group B Streptococcus Sepsis Infant, Newborn|
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|
|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|
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)
- Number of infants treated with antibiotics [ Time Frame: Study period ]
- Time elapsed from the onset of symptoms to the beginning of antibiotic treatment [ Time Frame: Study period ]
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
|Study Chair:||Sergio De Marini, MD||IRCCS Burlo Garofolo, Trieste, Italy|
|Principal Investigator:||Luigi Cantoni, MD||San Daniele Hospital, San Daniele, Italy|