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临床试验/NCT04817878
NCT04817878Unknown不适用

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

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,400
试验地点
1
主要终点
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction

研究概览

简要总结

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.

详细描述

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
24 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction

时间窗: 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)

Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age

时间窗: 2~3 years old

IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.

Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction

时间窗: 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.

Assessment of small head circumference of preterm infants at 2 to 3 years of age

时间窗: 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

Assessment of low weight of preterm infants at 2 to 3 years of age

时间窗: 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

Assessment of growth retardation of preterm infants at 2 to 3 years of age

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaomei Tong

Director, Head of peadiatrics, Clinical Professor

Peking University Third Hospital

研究点 (1)

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