Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Measure the catch-up growth degree.
研究概览
简要总结
A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •celiac disease diagnosis established at the V. Buzzi Children's Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations.
排除标准
- •patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease);
- •patients with additional chronic illnesses;
- •absence of the data required for the study;
- •patients with IgA deficiency, defined as IgA <20 mg/dl in children <3 years old or with levels that are below normal for their age.
结局指标
主要结局
Measure the catch-up growth degree.
时间窗: 6 and 24 month
Changes in the auxological weight variable in pediatric patients with celiac disease were measured 6 months and 24 months after they started a gluten-free diet. The change was expressed as an average daily weight increase and compared with the average increase expected for sex and age in a healthy population extrapolated from validated curves (Cacciari).
次要结局
- Calculate the degree of catch-up growth(6 and 24 month)
研究者
Elena Groppali
MD
ASST Fatebenefratelli Sacco