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临床试验/NCT03048409
NCT03048409已完成不适用

Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula

Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Feeding tolerance - vomiting

研究概览

简要总结

A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age on admission to facility
  • Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
  • Received enteral nutrition with an intact protein formula for a minimum of three days prior to a switch to a peptide-based formula
  • Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide-based formula
  • Receiving a peptide-based formula formula for ≥ 2 weeks
  • Have documentation of an assessment of feeding tolerance following the switch
  • Formulas received must be indicated for use in adults.

排除标准

  • Abdominal surgery (within past 30 days prior to switch)
  • Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
  • Having documented cow's milk protein allergy at time of switch
  • Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).

结局指标

主要结局

Feeding tolerance - vomiting

时间窗: Up to 30 days after formula switch

no change, tolerance improved, tolerance worsened

Tube feeding interruptions

时间窗: Up to 30 days after formula switch

Number of tube feeding interruptions

Feeding tolerance - Gastric residuals

时间窗: Up to 30 days after formula switch

no change, tolerance improved, tolerance worsened

Feeding tolerance - stool consistency issues

时间窗: Up to 30 days after formula switch

too hard, too loose

Feeding tolerance - abdominal distension/gas

时间窗: Up to 30 days after formula switch

no change, tolerance improved, tolerance worsened

Volume of formula consumed in a day vs. goal

时间窗: Up to 30 days after formula switch

documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch

Feeding tolerance - gagging/retching

时间窗: Up to 30 days after formula switch

no change, tolerance improved, tolerance worsened

次要结局

  • Protein intake(Up to 30 days after formula switch)
  • Medication use(Prior to and up to 30 days following formula switch.)
  • Caloric intake(Up to 30 days after formula switch)
  • Weight(Prior to and up to 30 days following formula switch.)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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