Mother to Newborn Transmission of Staphylococcus Aureus and the Dynamics of S. Aureus Carriage During the First Years of Life
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- S. aureus carriage
研究概览
简要总结
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
详细描述
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.
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Hours 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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:
- •300 consecutive women who are defined as S. aureus carriers (see definitions below).
结局指标
主要结局
S. aureus carriage
时间窗: 5 years
Carriage of S. aurues in any of the sites
次要结局
未报告次要终点
研究者
Gili Regev-Yochay MD
Director, Infection Control Unit
Sheba Medical Center