跳至主要内容
临床试验/NCT01825499
NCT01825499招募中不适用

Vermont Oxford Network Very Low Birth Weight Database of Infants <=1500 Grams or <=29 Weeks Gestational Age At Birth

Vermont Oxford Network1 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 1990年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60,000
试验地点
1
主要终点
Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner

研究概览

简要总结

Vermont Oxford Network maintains a database for live born infants <=1500 grams or <=29 weeks gestational age who are born at participating hospitals or admitted to them within 28 days of birth, regardless of where in the hospital the infant receives care.

详细描述

The Database collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment. The data collected includes information on:

  • Demographics of mother and infant
  • Mother's health, labor and delivery
  • Infant's health upon admission, procedures and interventions, and medical outcomes

These data are used to: provide member centers with reporting for use in quality improvement; examine associations between baseline characteristics, treatments, and outcomes; and track trends in incidences of disease and effectiveness of therapies.

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
— 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Any infant who is born alive and whose birth weight is <=1500 grams or <=29 weeks 6 days gestational age (inclusive) who is born at or admitted to a Vermont Oxford Network member center within 28 days of life without having first gone home, regardless of the where the infant receives care

排除标准

  • Stillborn infants
  • Infants discharged home prior to admission to a member center
  • Infants admitted after 28 days

结局指标

主要结局

Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner

时间窗: up to 1 year

Data items include infant and maternal characteristics, delivery room interventions, respiratory care and outcomes, surgeries, infections, other serious complications, and length of stay. Time frames for data collection include: characteristics of birth; at day 28; and at discharge. Tracking ends at discharge home (including for infants transferred out) or at one year.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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