Infant Feeding Practice and Gut Comfort: a Multi-country, Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,804
- 试验地点
- 16
- 主要终点
- An index score of overall GI symptom burden
研究概览
简要总结
Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.
详细描述
This is a cross-sectional single time point study. Infants and caregivers who come to a clinic for a routine health visit who wish to participate in the study by signing the consent form and meet all inclusion criteria/exclusion criteria will be enrolled.
At the visit, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) Infant Gastrointestinal Symptom (IGSQ)-13 items. Additionally, infant's anthropometrics (weight, length, head circumference) will be recorded. These anthropometrics will be measured by the researcher as part of the routine visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full term (37-42 weeks of gestation) singleton infant.
- •Postnatal age ≥ 6 weeks and ≤ 4 months
- •Parent as primary Caregiver and ≥ 18 years old
- •Exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks.
- •Evidence of personally signed and dated informed consent document by the infant's parent(s).
排除标准
- •Chronic illness necessitating medical follow up
- •Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up
- •Any known case of food allergy (e.g milk)
- •Caregivers who are not likely to comply with the study procedures
结局指标
主要结局
An index score of overall GI symptom burden
时间窗: single time point between 6 weeks to 4 months
Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
次要结局
- GI Symptoms(single time point between 6 weeks to 4 months)
- Stool characteristics(one day recall before study visit)
- Physician-reported and parent-reported Colic(Single time point between 6 weeks to 4 months)