Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Invasive Infection
研究概览
简要总结
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.
详细描述
All infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines.
The investigators goal was to target the time period these infants are at high-risk for infection or NEC and its associated mortality. The targeted time was the first 4 weeks of life or longer while intravenous access is still required. The average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in patients still requiring IV access (peripheral or central). The presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). This strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight <1000 grams or gestational age ≤28 weeks
- •less than or equal to 7 days of age
排除标准
- •greater than 7 days of age
研究组 & 干预措施
Hand hygiene
All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line.
Hand hygiene plus gloving
All staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line.
干预措施: Gloves (Other)
结局指标
主要结局
Invasive Infection
时间窗: Participants will be followed during their NICU hospitalization, an expected average of 3 months
Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis
Necrotizing enterocolitis (NEC)
时间窗: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
NEC will be defined as stage II or greater using Bell's modified criteria
次要结局
- Length of stay(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
- Mortality(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
- Hospital cost(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
- Common neonatal morbidities(Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
研究者
David A Kaufman
Prinicpal Investigator
University of Virginia
