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临床试验/NCT06000761
NCT06000761招募中不适用

Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and 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 218 人开始时间: 2023年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
218
试验地点
2
主要终点
Number of participants with oral microbiome dysbiosis.

研究概览

简要总结

Premature 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 dysbiosis (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 168 VLBW infants for 4 weeks following birth.

详细描述

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 dysbiosis (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. Premature VLBW infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. A dearth of information exists regarding oral care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (NICU) which may negatively affect their health. Thus, research regarding the effect of frequent, standardized oral care on the health of VLBW infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. If successful, this research could change practice in NICUs across the nation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

All de-identified saliva and breast milk samples will be conducted at a UF lab outside of Shands. ETT culture samples will also be de-identified before sending to Shands CoreLab. Investigators determining clinical outcomes will be blinded to group allocation

入排标准

年龄范围
1 Hour 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Mother ≥18 years of age
  • ≤ 30 weeks gestation
  • Born weighing ≤ 1500 grams

排除标准

  • Congenital anomalies of the face, lungs, or gastrointestinal system
  • Not expected to live > 7 days following delivery.

研究组 & 干预措施

Group 1

Active Comparator

Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.

干预措施: Standardized oral Care (Procedure)

Group 2

Active Comparator

Standardized oral care performed every 3-4 hours using sterile water.

干预措施: Standardized oral Care (Procedure)

Group 3

Active Comparator

Standardized oral care performed every 12 hours using sterile water.

干预措施: Standardized oral Care (Procedure)

结局指标

主要结局

Number of participants with oral microbiome dysbiosis.

时间窗: 0-28 days

Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

次要结局

  • Number of days requiring respiratory support(0-60 days)
  • Number of participants with ventilator associated pneumonia(0-28 days)
  • Number of participants with bronchopulmonary dysplasia(0-60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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