Prevalence of Premature Birth History Among Type 1 Diabetes Mellitus (T1D) Patients and Characteristics of Premature Born Children Who Develop T1D Compared With Those Who do Not
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- prematurity prevalence among T1D patients
研究概览
简要总结
The aims of this study are:
- To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel.
- To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.
详细描述
A national cohort study, including linkage of data from 13 pediatric diabetes centers and Israeli National Registries, including all patients with T1D born during 1990-2013. Data collected includes: ethnicity, gestational age, birth season, age and season at T1DM diagnosis, and presence of autoimmunity in family. The prevalence of prematurity among T1D is compared to the non-diabetic general population registry of 2000-2013. Additional comparisons are between T1D patients born term and preterm, aimed to unveil specific influencing clinical and epidemiological factors.
In the latter part of the study, a multi-centered, paired case-control study is performed.
Preterm born T1D patients will be paired to matched non-diabetic children at a ratio of 3:1, according to medical center, sex, gestational week of birth, season and year of birth. Data collected includes: ethnicity, family history of autoimmune diseases, age and type of first enteral nutrition, and pharmacological exposures.
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
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with T1D
- •Patients treated in one of the 13 participating centers
- •For the case-control portion of the study, all children born between 1.1.1990-31.12.2013 and admitted to NICU medical centers that have been included in the original cohort portion
- •Patients for whom a complete medical record is available
排除标准
- •Lack of birth data
- •Unknown type of diabetes
- •For case control portion, an incomplete medical record/inadequate documentation
结局指标
主要结局
prematurity prevalence among T1D patients
时间窗: 1 years
the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population
次要结局
- food exposure of premature who developed T1DM compared with prematures who did not develop diabetes(1 years)
- Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes(1 years)
研究者
Assaf Harofeh MC
Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center