跳至主要内容
临床试验/NCT04098679
NCT04098679招募中不适用

CONCEPTT Kids Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial

University of Calgary4 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
174
试验地点
4
主要终点
IQ

研究概览

简要总结

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy).

The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

详细描述

The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.

The other procedures will include:

  1. the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1);
  2. ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3);
  3. Social Responsiveness Scale-2 for ASD behaviours (4);
  4. Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5)
  5. Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7).

Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.

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 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of women who participated in the CONCEPTT trial at selected recruiting sites.

排除标准

  • Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

结局指标

主要结局

IQ

时间窗: 2 years

IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)

次要结局

  • ASD(2 years)
  • NEPSY-II(2 years)
  • Adiposity(2 years)
  • CCC-2/LUI(2 years)
  • Demographics(2 years)
  • ADHD(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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