Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
研究概览
简要总结
This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 4-6 months of age at time of consent
- •Provision of signed and dated informed consent form parent/guardian(s)
- •Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
- •In good general health as evidenced by medical history reported by the parent/guardian(s)
- •No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
排除标准
- •Known physician confirmed allergies to any of the ingredients in SO at the time of consent
- •Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
- •Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
- •Sibling in the home is already enrolled in the study
结局指标
主要结局
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
时间窗: 12 months
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
次要结局
- Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups(12 months and 18 months)
- Convenience, score through a questionnaire(12 months)
- Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score(Baseline)
- Proportion of participants compliant to daily feeding protocols, measured through a questionnaire(12 months)
- Proportion of participants on SpoonfulONE compared to the proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire(12 months and 18 months)
- Mean age of participants when first introduced to various food groups, measured through a questionnaire(12 months)
- Diet diversity, score(12 months)