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Mother to Newborn Transmission of Staphylococcus Aureus and Dynamics of S.Aureus Carriage During the First Years Life

Mother to Newborn Transmission of Staphylococcus Aureus and the Dynamics of S. Aureus Carriage During the First Years of Life

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03064373
Enrollment
600
Registered
2017-02-27
Start date
2008-12-17
Completion date
2023-06-17
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus

Keywords

S. aureus, carriage, mother-neonatal transmission, microbiome

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

Detailed description

Design: prospective cohort study which will examine the risk of exposure to S. aureus carrier mother on the outcome: S. aureus carriage by newborns following delivery and at discharge. 1. Risk of vertical transmission during delivery will be assessed by comparing a cohort of newborns to vaginal S. aureus carrier mothers to a cohort of newborns of mothers not carrying S. aureus vaginally. 2. Risk of horizontal transmission during the first days of life will be assessed by following a cohort of newborns not colonized on delivery day. The main exposure of interest is maternal nasal SA carriage.Target populations: 300 mother - newborn pairs. Setting: Sheba Medical Center obstetrical unit and nursery Gravid women will be recruited during antenatal visit at the Sheba medical Center, 1-4 weeks prior to labor. Women who will agree to participate and sign an informed consent will be screened for nasal and vaginal carriage of S. aureus. Newborns will be screened on delivery day and on discharge day. Inclusion criteria: 1. Gravid women expected to deliver within 4 weeks. 2. Women who agree to participate and sign an informed consent 3. Women who are S. aureus carriers at the time of recruit. Exclusion criteria: 1. Prolonged (\>6 days) newborn hospitalization. 2. Women who did not give birth eventually at the Sheba Medical Center. 3. Women who's newborns were not screened at least once during delivery hospitalization. Enrollment: 300 consecutive women who are defined as S. aureus carriers (see definitions below). Screening will include: Stage I before discharge: 1. Women - nasal screenings: A) On recruitment day (\ 1-4 weeks before labor), B) During hospitalization for delivery. Vaginal screening will be performed during the routine gynecologic examination on delivery day. 2. Newborns - will be screened A) On birth day, at entrance to the nursery. B) On discharge day. Screening will include nasal nares, umbilical, ear and rectal swabbing on each screening while hospitalized. 3. Data collection by questionnaires filled by recruited women. 4. Data collection from medical files of the maternity ward. Stage II after discharge until age 5 years: 1. Mothers - monthly nasal swab for 12 months. 2. Children - monthly nasal, nasopharyngeal and rectal swabs for 12 months. 3. Same screen annually until the child is 5years old. 4. Data collection by questionnaires filled by the mothers.

Interventions

None listed

Sponsors

The Israel Science Foundation
CollaboratorUNKNOWN
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 5 Years
Healthy volunteers
Yes

Inclusion criteria

1. Gravid women expected to deliver within 4 weeks. 2. Women who agree to participate and sign an informed consent 3. Women who are S. aureus carriers at the time of recruit.

Exclusion criteria

1. Prolonged (\>6 days) newborn hospitalization. 2. Women who did not give birth eventually at the Sheba Medical Center. 3. Women who's newborns were not screened at least once during delivery hospitalization. Enrollment: 300 consecutive women who are defined as S. aureus carriers (see definitions below).

Design outcomes

Primary

MeasureTime frameDescription
S. aureus carriage5 yearsCarriage of S. aurues in any of the sites

Countries

Israel

Contacts

Primary ContactGili Regev-Yochay, MD
gili.regev.y@gmail.com052-6666197
Backup ContactAyala Maayan-Metzger, Prof.
Ayala.Maayan@sheba.health.gov.il052-6669324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026