Management of Infants Born to Group B Streptococcus Positive Mothers.

NCT00716781 | Completed

• 1 other identifier: GBS FVG 2004-2006
• Study Type: observational
• Target: 16,394
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Group B Streptococcus; Sepsis; Infant, Newborn

Keywords

Group B streptococcus; Sepsis; Infants; Diagnosis; Physical examination; Laboratory tests

Outcome Measures

Primary Outcomes (1)

• Number of infants treated with antibiotics

  Study period

Secondary Outcomes (1)

• Time elapsed from the onset of symptoms to the beginning of antibiotic treatment

  Study period

Study Arms (2)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All newborns born in Friuli Venezia Giulia Region (Italy) during the study period

You may qualify if:

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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead
• Friuli Venezia Giulia Regional Health Authority: collaborator

Related Publications (1)

• 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.

  PMID: 23477995 DERIVED

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio De Marini, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Luigi Cantoni, MD

  San Daniele Hospital, San Daniele, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 16, 2008

Record last verified: 2008-07