A Prospective/Retrospective Chart Review of the Effects of a Probiotic Dietary Supplement on Days of Total Parenteral Nutrition in Two Neonatal Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of days on total parenteral nutrition
研究概览
简要总结
The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants < 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500 grams or GA < 32 weeks
排除标准
- •Life threatening congenital anomalies
- •Transfers to another facility prior to discharge home
- •Investigator discretion to exclude if deemed necessary
结局指标
主要结局
Number of days on total parenteral nutrition
时间窗: 30 days
Evaluate the effects of a probiotic dietary supplement (Similac Probiotic Tri-Blend) on number of days on total parenteral nutrition (TPN) in infants admitted to the Neonatal Intensive Care Unit (NICU).
次要结局
- Impact on neonatal growth(30 days)
- Feeding Intolerance(30 days)