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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet and helmet education | Experimental | 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. |
|
| Helmet education | Active Comparator | Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicycle helmet from Bell Sports Inc. | Other | As described under the respective arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Wearing Helmet | Baseline (Survey 1) and 5 months (Survey 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary O Aaland, MD, FACS | Parkview Hospital Trauma Center | Study Director |
| Thein H Zhu, MBBS, FACE | Parkview Hospital Trauma Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Action of Northeast Indiana (CANI) Inc - Head Start | Fort Wayne | Indiana | 46802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| Result Publication link | View source |
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Although 285 received Helmet Education only, 68 participants had prior helmet ownership and therefore were considered for further analysis.
609 participants were enrolled in the study and 2 were later known that they did not meet study inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Bicycle helmet from Bell Sports Inc.: As described under the respective arm |
| FG001 | 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. Bicycle helmet education only: As described under the respective arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Bicycle helmet from Bell Sports Inc.: As described under the respective arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Wearing Helmet | Analysis reflect population that owned the helmet during each survey | Posted | Number | Percentage of Participants | Baseline (Survey 1) and 5 months (Survey 2) |
|
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Adverse Event data was not collected per Arm; therefore a single Arm is reported.
Other Adverse Events were monitored for the study however that detailed information is not available, because the data is no longer accessible.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls from bicycle resulting in severe injury to seek emergency care | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thein Zhu | Parkview Health | 260-266-1279 | thein.zhu@parkview.com |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D005151 | Facial Injuries |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| Bicycle helmet education only | Other | As described under the respective arm |
|
|
| BG001 | 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. Bicycle helmet education only: As described under the respective arm |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above. Bicycle helmet education only: As described under the respective arm |
|
|
|
| Secondary | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Number of injuries by helmet wearing status as reported | Analysis population includes all participants that owned a helmet and available data for this assessment | Posted | Number | Injuries | 5 months |
|
|
|
| 9 |
| 607 |
| 0 |
| 0 |
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| Helmet riders (Face - upper/mid) |
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| Non-Helmeted riders (Head injuries) |
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| Non-Helmeted riders (Face - all portions) |
|
| Non-Helmeted riders (Face - upper/mid) |
|