跳至主要内容
临床试验/NCT05167318
NCT05167318进行中(未招募)不适用

Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

University of Florida2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

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

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

No Intervention

Infants will receive standardized oral care every 12 hours for 4 weeks

every 3-4 hour oral care

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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