Skip to main content
OpenTrials
Completed

NCT Number: NCT00716781

Management of Infants Born to Group B Streptococcus Positive Mothers.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Group B Streptococcus Disease Infant, Newborn Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of infants treated with antibiotics

    Time frame: Study period

Secondary outcomes

  1. Time elapsed from the onset of symptoms to the beginning of antibiotic treatment

    Time frame: Study period

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Collaborators

  • Friuli Venezia Giulia Regional Health Authority

Registry information

Official study title

Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 16, 2008
Registry last updated
Jul 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.