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临床试验/NCT01054846
NCT01054846已完成不适用

The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana

Parkview Hospital, Indiana2 个研究点 分布在 1 个国家目标入组 609 人开始时间: 2008年5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
609
试验地点
2
主要终点
Percentage of Participants Wearing Helmet

研究概览

简要总结

  • To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
  • To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

详细描述

Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.

The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
  • The child must possess a bicycle or a riding toy to ride
  • The child's caregiver speaks English or Spanish

排除标准

  • Age less than two or greater than 5-year olds
  • 3-5 year old children that do not own a bicycle or a riding toy to ride
  • The child's caregiver does not speak English or Spanish.

结局指标

主要结局

Percentage of Participants Wearing Helmet

时间窗: Baseline (Survey 1) and 5 months (Survey 2)

次要结局

  • Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners(5 months)

研究者

发起方
Parkview Hospital, Indiana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thein H Zhu

Trauma Epidemiologist

Parkview Hospital, Indiana

研究点 (2)

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