Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Development of weight, length, and head circumference
研究概览
简要总结
A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.
详细描述
The study collects growth data from 58 participating infants whose parents autonomously decided to use the dairy and plant based infant formula for their infant daily within the first three months of their infant's life, either supplemental to breastfeeding or as sole source of feeding. Parents are asked to complete 2-3 online questionnaires in which data is collected on infant growth (as assessed during regular visits to the Municipal Child Healthcare Clinic), feeding characteristics, parent and infant experience with the product, and whether their infant has been to a doctor or is taking medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents autonomously decided to feed their infant with at least one bottle per day of dairy and plant based infant formula in combination with breastfeeding or as sole source of feeding.
- •Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product
- •Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
- •Infant is being fed daily with dairy and plant based infant formula at time of enrolment
排除标准
- •Infant started feeding with dairy and plant based infant formula >3 months ago at time of enrolment
- •Participation of the infant in any other studies involving infant formula feeding (products) concomitantly
结局指标
主要结局
Development of weight, length, and head circumference
时间窗: 5 Months +2 weeks
Agreed clinical experts' judgement about development of weight, length and head circumference (adequate/inadequate) as measured at the Municipal Child Healthcare Clinic visits and transcribed by the parents in a digital tool
次要结局
- Development of length, BMI, and head circumference(5 Months + 2 weeks)
- Experience of parent and infant(after using product for 2 and 5 Months)
- Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age(5 Months + 2 weeks)