Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Prevalence of FGID
研究概览
简要总结
The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:
- evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life
- describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.
详细描述
Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic.
Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed.
Z-scores for weight, length and head circumference will be calculated according to the World Health Organization (WHO) standards.
Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods.
The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants).
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
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants with gestational age at birth < 31 weeks
- •infants with gestational age at birth < 37 weeks and major respiratory or neurologic morbidity
- •infants with history of perinatal asphyxia
排除标准
- •lack of informed consent
- •diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
结局指标
主要结局
Prevalence of FGID
时间窗: 3, 6, 12, 24 months of corrected age
Occurrence of FGID (percentage of patients)
Frequency of FGID
时间窗: 3, 6, 12, 24 months of corrected age
Frequency of FGID (i.e. number of symptoms per day)
Severity of FGID
时间窗: 3, 6, 12, 24 months of corrected age
Severity (scales from 0 to 10 for increasing values) of FGID
次要结局
- Somatic growth: weight(3, 6, 12, 24 months of corrected age)
- Somatic growth: head circumference(3, 6, 12, 24 months of corrected age)
- Somatic growth: length(3, 6, 12, 24 months of corrected age)