跳至主要内容
临床试验/NCT07143825
NCT07143825招募中不适用

A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Mortality rate

研究概览

简要总结

The goal of this nationwide multicenter observational study is to comprehensively investigate the severity of Small Vulnerable Newborns (SVN) issues across China and to propose further preventive and intervention measures. The primary aim is to provide a thorough description of SVN problems using a unified definition and framework, and to develop targeted prevention strategies.

Participating centers across the country will collect clinical data on vulnerable newborns under their care and complete detailed questionnaires to support this research.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Newborns diagnosed as vulnerable infants at the participating hospitals between January 1 and December 31, 2024;
  • •Meeting any one of the following criteria:
  • •Diagnosed as small for gestational age (SGA): birth weight below the 10th percentile for infants of the same gestational age and sex;
  • •Preterm infants: gestational age less than 37 weeks;
  • •Low Birth Weight (LBW) infants: birth weight less than 2,500 grams.

排除标准

  • •Incomplete medical records due to missing data preventing comprehensive case evaluation.

结局指标

主要结局

Mortality rate

时间窗: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

Number of small vulnerable newborns

时间窗: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

次要结局

  • Incidence of complications in small vulnerable newborns(From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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