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临床试验/NCT06021691
NCT06021691招募中不适用

A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children

Gansu Provincial Maternal and Child Health Care Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
delayed language development in children

研究概览

简要总结

The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

详细描述

Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

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
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.

排除标准

  • diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
  • neurological and hereditary metabolic diseases; (iv) deaf father/mother.

结局指标

主要结局

delayed language development in children

时间窗: 2023.1-2025.11

"Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."

次要结局

未报告次要终点

研究者

发起方
Gansu Provincial Maternal and Child Health Care Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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