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临床试验/NCT03488758
NCT03488758已完成不适用

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Centre Hospitalier Intercommunal Creteil28 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
28
主要终点
Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

研究概览

简要总结

To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

详细描述

This is a feasibility study to determine the utility of two new standardized psychometric tools for paediatricians to assess and manage feeding difficulties in formula fed infants. Baby Eating Behaviour Questionnaire (BEBQ) and Montreal Children's Hospital Feeding Scale (MCH-Feeding Scale) will be used in this study.

The secondary objectives are to determine if these tools can then measure the changes in behaviour after introducing two formula that differ in the sources of protein, ie formula made from whole goat milk compared to a conventional formula made from cow milk proteins. The quality of life and general health outcomes of these infants will also be monitored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Months 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy infants aged 2-3 months, predominantly formula fed

排除标准

  • Infants born less than 37GA
  • Confirmed or suspected cow milk protein allergy
  • Predominantly breast fed
  • Infants suffering from chronic disease

结局指标

主要结局

Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

时间窗: 1 month

Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

次要结局

  • Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale(1 month)
  • Quality of life assessed by QUALIN(1 month)
  • Formula liking, using 4-point visual analog scale (VAS)(1 month)
  • Incidences of rash(1 month)
  • Incidences of dry skin(1 month)
  • Incidences of eczema(1 month)
  • Gastrointestinal symptoms(1 month)
  • Weight(1 month)
  • Height(1 month)
  • head circomference(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (28)

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