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Impact of Helmet Use in Preschool Children

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ClinicalTrials.gov Identifier: NCT01054846
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : November 18, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Thein H Zhu, Parkview Hospital, Indiana

Brief 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

Condition or disease Intervention/treatment Phase
Head Injuries Facial Injuries Other: Bicycle helmet from Bell Sports Inc. Other: Bicycle helmet education only Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 609 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  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



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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.

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

Additional Information:
Publications of Results:
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 Posted: January 22, 2010    Key Record Dates
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