Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Type of of bacterial in the oral cavity
研究概览
简要总结
Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 72 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 32 weeks
- •birth weight < 1500 grams
- •mother is English speaking
- •mother is > 18 years of age.
排除标准
- •Congenital anomalies of the face, lungs, or gastrointestinal system
- •not expected to survive
研究组 & 干预措施
every 12 hour oral care
Infants will receive standardized oral care every 12 hours for 4 weeks
every 3-4 hour oral care
Infants will receive standardized oral care every 3-4 hours for 4 weeks
干预措施: frequent standardized oral care (Other)
结局指标
主要结局
Type of of bacterial in the oral cavity
时间窗: weekly for 4 weeks
microbial analysis of the oral microbiome
次要结局
- Incidence of chronic lung disease(Up to 100 days)
- Days of respiratory support(Up to 100 days)
