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Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors

2021年3月23日 更新者:Xiaomei Tong、Peking University Third Hospital
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.

研究概览

详细说明

Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.

In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.

研究类型

观察性的

注册 (预期的)

2400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing
      • Peking、Beijing、中国、100191
        • 招聘中
        • Peking University Third Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5个月 至 8个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

All preterm infants born during the study period

描述

Inclusion Criteria:

  • All preterm infants born less than 37 weeks during the study period

Exclusion Criteria:

  • Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Late preterm infant group
Gestational age 33 weeks-36 weeks
Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
Very premature infant group
Gestational age 28 weeks-32 weeks
Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
Super preterm infant group
Gestational age less than 28 weeks
Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
大体时间:correct gestational age 36~40 weeks
According to Fenton 2003 growth curve of premature infants, the weight, length, and head circumference of preterm infants with corrected gestational age of 36-40 weeks were evaluated, If the weight, length and head circumference are lower than the 10th percentile of the corresponding gestational age, the child is diagnosed as EUGR(extrauterine growth retardation)
correct gestational age 36~40 weeks
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
大体时间:correct gestational age 36~40 weeks
IF the NBNA score of preterm infants at 36-40 weeks of correction is lower than 36, and the abnormal GMs is evaluated, the child is diagnosed as neurodevelopmental retardation.
correct gestational age 36~40 weeks
Assessment of low weight of preterm infants at 2 to 3 years of age
大体时间:2~3 years old
Compared with the same age and gender reference population standard, children's weight below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as low weight
2~3 years old
Assessment of growth retardation of preterm infants at 2 to 3 years of age
大体时间:2~3 years old
Compared with the same age and gender reference population standard, children's height below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as growth retardation
2~3 years old
Assessment of small head circumference of preterm infants at 2 to 3 years of age
大体时间:2~3 years old
Compared with the same age and gender reference population standard, the children's occipitofrontal circumference (OFC) less than 2 standard deviations (SD) of the mean OFC (i.e. less than the 3rd percentile) is diagnosed as small head circumference
2~3 years old
Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
大体时间:2~3 years old
IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
2~3 years old

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:xiaomei tong, Ph.D.、Peking University Third Hospital
  • 研究主任:yanmei chang, Ph.D.、Peking University Third Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月1日

初级完成 (预期的)

2023年11月30日

研究完成 (预期的)

2023年11月30日

研究注册日期

首次提交

2021年3月16日

首先提交符合 QC 标准的

2021年3月23日

首次发布 (实际的)

2021年3月26日

研究记录更新

最后更新发布 (实际的)

2021年3月26日

上次提交的符合 QC 标准的更新

2021年3月23日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • bysy2020-423-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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