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临床试验/NCT02912065
NCT02912065已完成不适用

Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment

Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Feeding tolerance after switching to Peptide based formula

研究概览

简要总结

A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

详细描述

Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
13 Months 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •13 months to < 18 years of age on admission to facility
  • •Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
  • •Received enteral nutrition with an intact protein formula for a minimum of two weeks 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
  • •Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
  • •Formulas received must be indicated for use in children or adults (not infant formulas).

排除标准

  • •Recent abdominal surgery, change in tube position/placement (within past 30 days)
  • •Cow's milk protein allergy
  • •Any current infections including upper respiratory, viral, gastroenteritis, wound infection.

结局指标

主要结局

Feeding tolerance after switching to Peptide based formula

时间窗: up to 30 days post formula switch

Categorized as no change, tolerance improved, tolerance worsened.

次要结局

  • Intake of target feeding volume(up to 30 days post formula switch)
  • Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch.(up to 30 days post 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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