Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2022-06-15
2022-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention
Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.
CCS System- Prototype
Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
Control
Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.
CCS System- Control
The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
Interventions
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CCS System- Prototype
Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
CCS System- Control
The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
Eligibility Criteria
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Inclusion Criteria
* Has harnessed/fastened a child into a car seat in the last five (5) years
* Has a valid driver's license
Exclusion Criteria
* Participant cannot install a safety seat due to a physical or health limitation
18 Years
75 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
University of Alabama at Birmingham
OTHER
Minnesota HealthSolutions
INDUSTRY
Responsible Party
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Sara Seifert
MPH
Principal Investigators
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Sara Seifert, MPH
Role: PRINCIPAL_INVESTIGATOR
Minnesota HealthSolutions
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Centers for Disease Control and Prevention. Ten leading causes of unintentional injury deaths, United States, 2016, all races, both sexes. https://webappa.cdc.gov/cgi-bin/broker.exe. Published 2016.
Centers for Disease Control and Prevention. Fatal Injury Data. https://www.cdc.gov/injury/wisqars/fatal.html. Accessed January 5, 2019.
National Highway Traffic Safety Administration. Traffic Safety Facts 2008 Data: Young Drivers. Vol 2010. Washington, DC: US Department of Transportation; 2008. doi:DOT HS 811 169
National SAFE KIDS Campaign and NHTSA Child Passenger Safety Technician Program Participant Manual. :C-4.
Li HR, Pickrell TM, KC S. The 2015 National Survey of the Use of Booster Seats. Washington, DC; 2016. www.ntis.gov.
Greenwell NK. Results of the National Child Restraint Use Special Study. Washington, DC; 2015. www.ntis.gov.
Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.
Arbogast KB, Durbin DR, Cornejo RA, Kallan MJ, Winston FK. An evaluation of the effectiveness of forward facing child restraint systems. Accid Anal Prev. 2004 Jul;36(4):585-9. doi: 10.1016/S0001-4575(03)00065-4.
Brown J, Bilston L, McCaskill M. Injury implications of inappropriate use of adult seatbelt systems for children aged 2-8. Australas Road Res Polic Educ Conf. 2003;7(2):81-87.
Brown J, McCaskill ME, Henderson M, Bilston LE. Serious injury is associated with suboptimal restraint use in child motor vehicle occupants. J Paediatr Child Health. 2006 Jun;42(6):345-9. doi: 10.1111/j.1440-1754.2006.00870.x.
Lutz N, Arbogast KB, Cornejo RA, Winston FK, Durbin DR, Nance ML. Suboptimal restraint affects the pattern of abdominal injuries in children involved in motor vehicle crashes. J Pediatr Surg. 2003 Jun;38(6):919-23. doi: 10.1016/s0022-3468(03)00124-6.
Valent F, McGwin G Jr, Hardin W, Johnston C, Rue LW 3rd. Restraint use and injury patterns among children involved in motor vehicle collisions. J Trauma. 2002 Apr;52(4):745-51. doi: 10.1097/00005373-200204000-00023.
Weinstein EB, Sweeney MM, Garber M, Eastwood MD, Osterman JG, Roberts JV. The Effect of Size Appropriate and Proper Restraint Use on Injury Severity of Children. In: 2nd Child Occupant Protection Symposium. Society of Automotive Engineers (SAE); 1997:181-186.
Winston FK, Durbin DR, Kallan MJ, Moll EK. The danger of premature graduation to seat belts for young children. Pediatrics. 2000 Jun;105(6):1179-83. doi: 10.1542/peds.105.6.1179.
Decina LE, Lococo KH. Misuse of child restraints. 2004. http://icsw.nhtsa.gov/people/injury/research/misuse/images/misusescreen.pdf.
Klinich KD, Manary MA, Flannagan CAC, et al. Labels, Instructions, and Features of Convertible Child Restraint Systems (CRS): Evaluating Their Effects on CRS Installation Errors. Washington, DC; 2010.
Wegner MV, Girasek DC. How readable are child safety seat installation instructions? Pediatrics. 2003 Mar;111(3):588-91. doi: 10.1542/peds.111.3.588.
Doak CC, Doak LG, Root JH. Teaching Patients with Low Literacy Skills. 2nd ed. Philadelphia: JB Lippincott Co.; 1996.
Participants Central. Prevent child heatsroke in cars. http://www.safercar.gov/participants/InandAroundtheCar/heatstroke.htm. Accessed December 7, 2016.
Singh S, Stern S, Subramanian R. Not-in-Traffic Surveillance: Non-Crash Fatalities and Injuries.; 2015.
Rudd R, Prasad A, Weston D, Wietholter K. Functional Assessment of Unattended Child Reminder Systems. Washington, DC; 2015.
Null J. Heatsroke deaths of children in vehicles. https://noheatstroke.org/index.htm. Accessed January 5, 2019.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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20-017790
Identifier Type: -
Identifier Source: org_study_id
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