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临床试验/NCT01443091
NCT01443091已完成不适用

Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age

研究概览

简要总结

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.

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 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • infants with a birth weight less than 1500 grams (or 3.3 lbs) born at Penn State Hershey Medical Center and admitted to the PSUCH NICU immediately after birth

排除标准

  • Infants with major congenital anomalies or chromosomal syndromes incompatible with life Infants of mothers not willing to provide colostrum for their infant in the first week of life Infants of mothers with known HIV, Hepatitis B or Hepatitis C as these infections may be transmitted through breast milk

结局指标

主要结局

Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age

时间窗: 2 weeks of age

次要结局

  • time to reach full enteric feeds(first few weeks of age)
  • episodes of suspected or culture positive sepsis(initial hospital stay 1-3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen M. Glass

Assistant Professor of Pediatrics

Milton S. Hershey Medical Center

研究点 (2)

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