Phase 2
N=92
Minnesota HealthSolutions Cellular Car Seat Study
Child Safety Seat Harness Tension
Bottom Line
View on ClinicalTrials.gov: NCT05552027 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Installation Errors — 21; 41; 17; 32 Participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CCS System- Prototype (Device); CCS System- Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Minnesota HealthSolutions
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Installation Errors |
21; 41; 17; 32; 18; 33 | <.001 sig |
Summary
The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.
Eligibility Criteria
Inclusion Criteria
- Males or Females ages 18-75 years
- Has harnessed/fastened a child into a car seat in the last five (5) years
- Has a valid driver's license
Exclusion Criteria
- Non-fluency in written and/or spoken English
- Participant cannot install a safety seat due to a physical or health limitation
Data sourced from ClinicalTrials.gov (NCT05552027). 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.