Clinical Trials Directory

Trials / Completed

CompletedNCT01054846

Impact of Helmet Use in Preschool Children

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
609 (actual)
Sponsor
Parkview Hospital, Indiana · Academic / Other
Sex
All
Age
3 Years – 5 Years
Healthy volunteers
Not accepted

Summary

* 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

Detailed description

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).

Conditions

Interventions

TypeNameDescription
OTHERBicycle helmet from Bell Sports Inc.As described under the respective arm
OTHERBicycle helmet education onlyAs described under the respective arm

Timeline

Start date
2008-05-01
Primary completion
2008-11-01
Completion
2009-01-01
First posted
2010-01-22
Last updated
2017-02-09
Results posted
2016-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01054846. Inclusion in this directory is not an endorsement.