跳至主要内容
临床试验/NCT03104946
NCT03104946已完成不适用

Clinical Research on the Predictive Effect of Neonatal Morbidities on the Poor Outcomes to Very Low Birth-weight and Extremely Low Birth-weight Infants

yangjie0 个研究点目标入组 834 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
834
主要终点
visual impairment

研究概览

简要总结

From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death, cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to observe the relationship between morbidities and poor outcomes. And the predictive effect on the number of the top three morbidities were analyzed by Logistic regression analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g.

排除标准

  • The very low birth weight infants didn't have any congenital disease.

结局指标

主要结局

visual impairment

时间窗: 1 year

do not pass okineticnystagmus

cognitive delay

时间窗: 1 year

mental development index(MDI)\<70

hearing impairment

时间窗: 1 year

do not pass auditory brainstem response (ABR)

次要结局

未报告次要终点

研究者

发起方
yangjie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yangjie

Director of Dept of Neonatology

Guangdong Women and Children Hospital

相似试验