Effects of Gestational Giabetes Mellitus on Neuropsychological Development and Physique Growth in Children:a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Changes in Peabody Developmental Motor Scales 2(PDMS-2) test results within 6 months of age
研究概览
简要总结
Abstract Gestational diabetes mellitus (GDM) refers to different degrees of glucose intolerance or impaired glucose tolerance,which are commonly found on non-diabetic persons during pregnancy.GDM is an important public health issue that has a huge impact on children's health.According to statistics,the global occurrence of GDM in 2017 was as high as 16.2%.As well as lifestyle changes that are leading to an increased number of women with overweightness and obesity,the increasing number of"older mothers"responding to the second-child policy are raising up the percentile of GDM by the year.infancy and pre-school age are the important stages of physical growth and psychomotor development.At present,there are few domestic and International studies on the impact of GDM on the health of children,and the conclusions are not the same.There is a lack of long-term follow-up and Chinese samples. This study focuses on the current new hotspot in the research of the children's health problems, based on the 1000-day life concept and theory of DOHaD. Prospective cohort study methods and real-world studies were used. To study and clarify the effect of GDM on the neuropsychological development and physical growth indicators of children in China, and further explore the possible mechanism of action and the related indicators of predictive value, looking for possible early intervention targets. The results are expected to expand the data sources of this type of research in China, improve the data quality and clarify the characteristics of this type of population in China, and provide data support for the revision of maternal and child health related policies.
详细描述
- Introduction:
According to statistics, the occurrence of GDM in 2017 of China was roughly 14.8%. A preliminary test performed by the obstetrics outpatient department of the First People's Hospital of Chongqing Liangjiang New Area, China (Project partner) revels that the GDM percentile was 17.5%.
It is currently believed that GDM can affect the perinatal health of next generation including "giant children". Recently, the impact of GDM on the health of children in childhood has become a research hot spot. GDM is an important public health issue that has a huge impact on children's health.
"1000 days in the early life" refers to the period from the combination of sperm and egg to the second year of life, which has a profound impact on children's growth and development and adulthood health and even the health of their children. Children at this age are in the window period of interaction between genetics and environmental factors, and yet, are also in the "opportunity window" of epigenetic regulation. The disease and nutrition of pregnant mothers will greatly affect the growth and development of children in the first 1000 days of their lives, as well as the long-term health of the children and that of the children's children.
International studies have shown that the children of GDM mothers may have abnormalities in nervous system development, including cognitive memory impairment and bradykinesia. Recent studies have found that GDM diagnosed before 26 weeks of gestation can increase the risk of autism spectrum disorders in the 18-24-month-old children, and GDM treatment cannot reduce the risk. A study in Spain found that GDM significantly reduced test scores for language and gross motor development in 18 months old children(P<0.05).
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 Month 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term infant;
- •Apgar score>=7 at birth；
- •single birth;
- •no obvious birth defects;
- •no other perinatal diseases that seriously affecting growth and development;
- •no congenital or genetic metabolic diseases that affect intelligence development;
排除标准
- •mother with type 1 or type 2 diabetes before pregnancy;
- •the mother had no OGTT diagnosis results and was not diagnosed in strict accordance with the diagnostic criteria of GDM;
- •the mother had suffered from severe acute and chronic infectious diseases;
- •the mother has other pregnancy complications during pregnancy (hypertensionkidney disease,cardiovascular disease,liver disease,thyroid-related disease,cholestasis,severe anemia,etc.);
- •Mother's age>35 years old;
- •the infants developed diseases that severely affected metabolism or normal growth and development during the follow-up.
结局指标
主要结局
Changes in Peabody Developmental Motor Scales 2(PDMS-2) test results within 6 months of age
时间窗: 6 months
The PDMS-2 test performed at the age of 1 month,3 months,6 months, to compare the differences in test results between the children of the GDM group and the non-GDM group.The PDMS-2 scale included two relatively independent parts, gross motion assessment Scale and fine motion assessment scales. The gross motion assessment scale for infants younger than 1 years of age tests the ability of three areas: reflexes, stationary and locomotion,the fine motion assessment scale tests grasping,visual-motor Integration.The results are expressed in terms of gross motor quotient (GMQ),fine motor quotient (FMQ),and total motor quotient (TMQ).There are seven grades according to quotient(MQ is excellent between 131 and 165, MQ is good between 121 and 130, MQ is medium up between 111 and 120，MQ is medium between 90 and 100，MQ is medium down between 80 and 89, MQ is poor between 70 and 79, MQ is very poor between 35 and 69).
Changes in Gesell developmental scale test results within 6 months of age
时间窗: 72 months
The Gesell developmental scale test was performed at the age of 6 months,12 months,24 months,36 months,48 months,60 months and 72 months,to compare the differences in test results between the children of the GDM group and the non-GDM group.The Gesell developmental scale mainly measures five areas:adaptive behavior, gross motor, fine motor, Language behavior,personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation.
次要结局
- Change of the height for age Z-score(HAZ)blood routines(72 months)
- Change of the BMI for Age Z-score(BAZ)(72 months)
- Changes in mean red blood cell volume (MCV)(72 months)
- Change of the weight for Age Z-score(WAZ)(72 months)
- Changes in mean red blood cell hemoglobin concentration (MCHC)(72 months)
- Change of weight for height Z-score(WHZ)(72 months)
- Changes in hemoglobin(72 months)
- Changes in mean red blood cell hemoglobin (MCH)(72 months)
- Changes in platelet count (PLT)(72 months)
- Changes in percentage of RBC width distribution(RDW%)(72 months)
研究者
Chen Li
Vice Director,Professor
Children's Hospital of Chongqing Medical University