Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,908
- 试验地点
- 1
- 主要终点
- To determine the ROME IV Criteria score
研究概览
简要总结
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
详细描述
Primary:
To assess the prevalence of specific FGIDs (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms in infants and toddlers in Thailand, according to information provided by the parents.
Secondary:
To assess the impact of FGIDs (Infant regurgitation, Infantile colic and functional constipation) and related signs and symptoms of infants and toddlers on the quality of life (QoL) of parents/caretakers and family, according to information provided by the parents.
Exploratory:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Months 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of otherwise healthy infants and/or toddlers from one of the age groups: 3±1 months, 6±1 months, 9±1 months, 12±1 months, or 18±1 months
- •Parent answering the online survey questionnaire attends to the child more than 50% of the time
- •Informed consent from one or both parents (according to local laws) and/or legal guardian.
- •Parent should have reliable access to the internet and a reliable device such as a computer, tablet or smartphone to complete the online survey questionnaire
排除标准
- •Parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed
- •Inability of the parent to answer the survey questionnaire online.
- •Infants and Toddlers who underwent surgery under general anesthesia
结局指标
主要结局
To determine the ROME IV Criteria score
时间窗: 1 day
FGIDs according to the ROME IV criteria (infant regurgitation, infantile colic, and functional constipation), related signs and symptoms in infants and toddlers based on parent's response in the survey questionnaires. Scale measures 1-7
次要结局
- To measure Quality of Life using modified Pediatric Quality of Life Inventory™(1 day)