Evaluation of the Effectiveness of Chlorhexidine Bathing in Reducing Nosocomial Infections in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- bacteremia episodes per 1000 patient days
研究概览
简要总结
This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2% chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water according to gestational age and weight (e.g. standard bathing). The trial will take place in the Neonatal intensive care unit (NICU).
Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In the preliminary phase of the study we will establish the safety of chlorhexidine bathing using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation. Interim analysis for adverse events will be performed after each group of patients.
In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the study will be bathed three times a week with Chlorhexidine wash cloths during the initial 6-months study period (intervention), followed by standard bathing during the second 6-months period, then again intervention period for 6 months and standard bathing for 6-months. Total study period- 3 years.
Data collection will include all bloodstream infections as well as surveillance cultures
详细描述
The study will take place in the Neonatal intensive care unit (NICU) of Shaare-Zedek Medical Center
Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment.
Preliminary study:
In order to establish safety , we will enroll infants admitted to the NICU to three successive treatment groups , as follows: the first group will include term infants admitted to the NICU (gestational age 37+6 and >7 days old), the second group will include near-term infants (gestational age > 34+0 to 36+6 weeks and >7 days old) and the third group will include premature infants (gestational age >30+0 to 33+6 and >=10 days old). We intend to enroll up to 20 patients in each group, for a minimum of 200 patient days per group . All infants will be assigned for bathing three times a week with washcloths impregnated with 2% chlorhexidine gluconate (Clinell ® Chlorhexidine wash cloths, GAMA healthcare) for the duration of their NICU stay. The infant's skin will be monitored continuously as described below . In case of grade 3 or 4 reactions, the study interventions will be temporarily suspended, and the adverse event will be reported to the Helsinky committee and to the study steering committee. If no grade 3 or 4 reactions will be encountered after at least 200 patient days per group, enrollment to the subsequent group will be performed (e.g if no grade 3-4 reaction will be encountered for 200 patient days in group 1, we will start enrolling patients for group 2 etc.). If no grade 3-4 dermatitis is encountered in the preliminary study, we will initiate enrollment as described below.
In the subsequent phases of the study, :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants weighing ≥1500 grams and >=10 days of age
- •parents' informed consent
排除标准
- •infants weighing <1500 grams or <10days of age;
- •parents' refusal to sign informed consent.
结局指标
主要结局
bacteremia episodes per 1000 patient days
时间窗: 3 years
Number of bacteremia events per 1000 patient days during the intervention periods compared with the control periods.
次要结局
- Time to colonization(2 years)
- colonization with resistant bacteria(2 years)
- Colonization with resistant bacteria(2 years)
研究者
Dr. Maskit Bar-Meir
attending physician
Shaare Zedek Medical Center