Impact of Helmet Use in Preschool Children

Facial Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054846
• Other study ID #: Parkview - 001
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: February 7, 2017
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2017
• Source: Parkview Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Facial Injuries
• Head Injuries
• Wounds and Injuries

Intervention

Other:
• Bicycle helmet from Bell Sports Inc.
As described under the respective arm
• Bicycle helmet education only
As described under the respective arm

Locations

Country	Name	City	State
United States	Community Action of Northeast Indiana (CANI) Inc - Head Start	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Parkview Hospital, Indiana

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Wearing Helmet		Baseline (Survey 1) and 5 months (Survey 2)
Secondary	Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners	Number of injuries by helmet wearing status as reported	5 months

External Links

•   Result Publication link