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Impact of Helmet Use in Preschool Children

NCT01054846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2017-02-09

Study results available
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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

Conditions

  • Head Injuries
  • Facial Injuries

Interventions

OTHER

Bicycle helmet from Bell Sports Inc.

As described under the respective arm

OTHER

Bicycle helmet education only

As described under the respective arm

Sponsors & Collaborators

  • Parkview Hospital, Indiana

    lead OTHER

Principal Investigators

  • Mary O Aaland, MD, FACS · Parkview Hospital Trauma Center

  • Thein H Zhu, MBBS, FACE · Parkview Hospital Trauma Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054846 on ClinicalTrials.gov