Impact of Helmet Use in Preschool Children

Parkview Hospital, Indiana

Status: Completed

Conditions: Head Injuries; Facial Injuries

Treatments: Other: Bicycle helmet education only; Other: Bicycle helmet from Bell Sports Inc.

Study type: Interventional

Funder types: Other

Identifiers

NCT01054846

Parkview - 001

Details and patient eligibility

About

• 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

Full 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).

Enrollment: 609 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 2 patient groups

Helmet and helmet education

Experimental group

Description:

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.

Treatment:

Other: Bicycle helmet from Bell Sports Inc.

Helmet education

Active Comparator group

Description:

Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.

Treatment:

Other: Bicycle helmet education only