Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Colonization of umbilical stump
研究概览
简要总结
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). This study is a prospective, randomized controlled feasibility trial to evaluate three types of hygiene products on umbilical line stumps, on the effect of line colonization and subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be randomized into one of four study groups, three products against standard of care (no product). The three products that will be evaluated are currently being used in different capacities for skin care in the UVA NICU. The study hypothesizes that daily topical application of 1 or more antiseptic to the top of the umbilical stump will decrease colonization of the umbilical stump while umbilical lines are in place.
详细描述
Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as PICCs and surgically placed CVLin the NICU. (www.CDC.gov - NSHN 2010 Report). Routine care of the skin entry site (e.g. central line dressing care) is standard for other central lines, but there is no standard for care of the umbilical stump while umbilical lines are in place.
In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.
This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of once daily product application.
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 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*≤7 days of life
- •*Umbilical line(s) in place (UAC and/or UVC)
排除标准
- •*Not meeting inclusion criteria
研究组 & 干预措施
Povidone-Iodine (Betadine)
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
干预措施: Povidone-Iodine (Drug)
Chlorhexidine
Umbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place
干预措施: Chlorhexidine (Drug)
Pluronic
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied once a day to cord stump while umbilical line(s) are in place
干预措施: Pluronic (Drug)
Control (no application)
Control arm, no product is applied, which is standard of care.
干预措施: Control (Other)
结局指标
主要结局
Colonization of umbilical stump
时间窗: while umbilical lines are in place which is an average of 7 days
次要结局
- contact dermatitis(during intervention which is an average of 7 days)
- Late-onset infection(up to 120 days of life, transfer, death or discharge from NICU)
研究者
David A Kaufman
Medical Doctor
University of Virginia