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Impact of Helmet Use in Preschool Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054846
First Posted: January 22, 2010
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thein H Zhu, Parkview Hospital, Indiana
  Purpose
  • 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

Condition Intervention
Head Injuries Facial Injuries Other: Bicycle helmet from Bell Sports Inc. Other: Bicycle helmet education only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana

Resource links provided by NLM:


Further study details as provided by Thein H Zhu, Parkview Hospital, Indiana:

Primary Outcome Measures:
  • Percentage of Participants Wearing Helmet [ Time Frame: Baseline (Survey 1) and 5 months (Survey 2) ]

Secondary Outcome Measures:
  • 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


Enrollment: 609
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helmet and helmet education
Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Other: Bicycle helmet from Bell Sports Inc.
As described under the respective arm
Other Name: Bell bicycle helmets
Active Comparator: Helmet education
Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Other: Bicycle helmet education only
As described under the respective arm
Other Name: Bicycle helmet education

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054846


Locations
United States, Indiana
Community Action of Northeast Indiana (CANI) Inc - Head Start
Fort Wayne, Indiana, United States, 46802
Sponsors and Collaborators
Parkview Hospital, Indiana
Investigators
Study Director: Mary O Aaland, MD, FACS Parkview Hospital Trauma Center
Principal Investigator: Thein H Zhu, MBBS, FACE Parkview Hospital Trauma Center
  More Information

Additional Information:
Publications:
Zhu TH; Aaland MO; Kerrigan C; Schiebel R; Henry H; Hollister L. Preventable head and facial injuries by providing free bicycle helmets and education to preschool children in a head start program. Health 2011 3(11):689-97

Responsible Party: Thein H Zhu, Trauma Epidemiologist, Parkview Hospital, Indiana
ClinicalTrials.gov Identifier: NCT01054846     History of Changes
Other Study ID Numbers: Parkview - 001
First Submitted: January 21, 2010
First Posted: January 22, 2010
Results First Submitted: November 9, 2016
Results First Posted: November 18, 2016
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Thein H Zhu, Parkview Hospital, Indiana:
Bicycle helmet

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Facial Injuries
Trauma, Nervous System
Nervous System Diseases