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OpenTrials
Completed

NCT Number: NCT01054846

Impact of Helmet Use in Preschool Children

* 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

Completed

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Key information

Conditions

Head Injuries Craniocerebral Trauma Facial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Action of Northeast Indiana (CANI) Inc - Head Start

Fort Wayne, Indiana, 46802, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Bicycle helmet from Bell Sports Inc.

Other

As described under the respective arm

Other names: Bell bicycle helmets

Bicycle helmet education only

Other

As described under the respective arm

Other names: Bicycle helmet education

Primary outcomes

  1. Percentage of Participants Wearing Helmet

    Time frame: Baseline (Survey 1) and 5 months (Survey 2)

Secondary outcomes

  1. Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners

    Time frame: 5 months

    Number of injuries by helmet wearing status as reported

Sponsors and collaborators

Lead sponsor

Parkview Hospital, Indiana

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jan 22, 2010
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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