Trial Outcomes & Findings for Impact of Helmet Use in Preschool Children (NCT NCT01054846)

NCT ID: NCT01054846

Last Updated: 2017-02-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 609 participants
• Primary outcome timeframe: Baseline (Survey 1) and 5 months (Survey 2)
• Results posted on: 2017-02-09

Participant Flow

609 participants were enrolled in the study and 2 were later known that they did not meet study inclusion criteria.

Although 285 received Helmet Education only, 68 participants had prior helmet ownership and therefore were considered for further analysis.

Participant milestones

Measure	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	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
Overall Study STARTED	322	68
Overall Study COMPLETED	246	51
Overall Study NOT COMPLETED	76	17

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	76	17

Baseline Characteristics

Impact of Helmet Use in Preschool Children

Baseline characteristics by cohort

Measure	Helmet and Helmet Education n=322 Participants 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	Helmet Education n=68 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	Total n=390 Participants Total of all reporting groups
Age, Customized 3 years	87 Participants n=93 Participants	12 Participants n=4 Participants	99 Participants n=27 Participants
Age, Customized 4 years	125 Participants n=93 Participants	33 Participants n=4 Participants	158 Participants n=27 Participants
Age, Customized 5 years	110 Participants n=93 Participants	23 Participants n=4 Participants	133 Participants n=27 Participants
Sex: Female, Male Female	161 Participants n=93 Participants	38 Participants n=4 Participants	199 Participants n=27 Participants
Sex: Female, Male Male	161 Participants n=93 Participants	30 Participants n=4 Participants	191 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Survey 1) and 5 months (Survey 2)

Population: Analysis reflect population that owned the helmet during each survey

Outcome measures

Measure	Helmet and Helmet Education n=221 Participants 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	Helmet Education n=67 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
Percentage of Participants Wearing Helmet Baseline (Survey 1, n=99, 67)	65.6 Percentage of Participants	49.3 Percentage of Participants
Percentage of Participants Wearing Helmet 5 months (Survey 2, n=221, 45)	80.5 Percentage of Participants	62.2 Percentage of Participants

SECONDARY outcome

Timeframe: 5 months

Population: Analysis population includes all participants that owned a helmet and available data for this assessment

Number of injuries by helmet wearing status as reported

Outcome measures

Measure	Helmet and Helmet Education n=82 Participants 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	Helmet Education n=23 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
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Helmet riders (Head injuries)	2 Injuries	0 Injuries
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Helmet riders (Face - all portions)	12 Injuries	3 Injuries
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Helmet riders (Face - upper/mid)	3 Injuries	1 Injuries
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Non-Helmeted riders (Head injuries)	8 Injuries	2 Injuries
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Non-Helmeted riders (Face - all portions)	8 Injuries	3 Injuries
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners Non-Helmeted riders (Face - upper/mid)	3 Injuries	1 Injuries

Adverse Events

All Study Participants

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Study Participants n=607 participants at risk
General disorders Falls from bicycle resulting in severe injury to seek emergency care	1.5% 9/607 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.

Other adverse events

Adverse event data not reported

Additional Information

Thein Zhu

Parkview Health

Phone: 260-266-1279

Email: thein.zhu@parkview.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place