N/A
N=390
Impact of Helmet Use in Preschool Children
Head Injuries · Facial Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01054846 ↗Enrolled (actual)
390
Serious AEs
1.5%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants Wearing Helmet — 65.6; 49.3; 80.5; 62.2 Percentage of Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bicycle helmet from Bell Sports Inc. (Other); Bicycle helmet education only (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Parkview Hospital, Indiana
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Wearing Helmet |
65.6; 49.3; 80.5; 62.2 | <0.01 sig |
| SECONDARY Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners |
2; 0; 12; 3; 3; 1 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01054846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.