Mother to Newborn Transmission of Staphylococcus Aureus and Dynamics of S.Aureus Carriage During the First Years Life
1 other identifier
observational
600
1 country
1
Brief Summary
Staphylococcus aureus (SA) is a significant cause of community and hospital acquired infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have been reported in very young infants and newborns. Previous studies have suggested that the source of SA carriage in young children is SA carried by their mothers. Possible modes of transmission from mother to child are transmission during passage through a colonized birth canal, through lactation and/or close contact. We aim to 1) Define the route of transmission between mother and newborn. 2) Assess the dynamics of S. aureus carriage during the first years of life and specifically determine risk factors for becoming a persistent carrier of S. aureus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2008
CompletedFirst Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2023
CompletedFebruary 27, 2017
February 1, 2017
14 years
February 22, 2017
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
S. aureus carriage
Carriage of S. aurues in any of the sites
5 years
Eligibility Criteria
300 mother - newborn pairs.
You may qualify if:
- Gravid women expected to deliver within 4 weeks.
- Women who agree to participate and sign an informed consent
- Women who are S. aureus carriers at the time of recruit.
You may not qualify if:
- Prolonged (\>6 days) newborn hospitalization.
- Women who did not give birth eventually at the Sheba Medical Center.
- Women who's newborns were not screened at least once during delivery hospitalization.
- Enrollment:
- consecutive women who are defined as S. aureus carriers (see definitions below).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- The Israel Science Foundationcollaborator
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel, 5265601, Israel
Related Publications (1)
Leshem E, Maayan-Metzger A, Rahav G, Dolitzki M, Kuint J, Roytman Y, Goral A, Novikov I, Fluss R, Keller N, Regev-Yochay G. Transmission of Staphylococcus aureus from mothers to newborns. Pediatr Infect Dis J. 2012 Apr;31(4):360-3. doi: 10.1097/INF.0b013e318244020e.
PMID: 22189535BACKGROUND
Biospecimen
S. aureus and S. pneumoniae
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dror Charats, Prof.
IRB Committee.Sheba Medical Center Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Infection Control Unit
Study Record Dates
First Submitted
February 22, 2017
First Posted
February 27, 2017
Study Start
December 17, 2008
Primary Completion
December 17, 2022
Study Completion
June 17, 2023
Last Updated
February 27, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share