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OpenTrials
Completed

NCT Number: NCT05552027

Minnesota HealthSolutions Cellular Car Seat Study

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCS System- Prototype

Device

Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)

CCS System- Control

Device

The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).

Primary outcomes

  1. Number of Participants With Installation Errors

    Time frame: Once during the only study visit: up to 30 mins

    For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).

Sponsors and collaborators

Lead sponsor

Minnesota HealthSolutions

Industry

Collaborators

  • Children's Hospital of Philadelphia
  • University of Alabama at Birmingham

Registry information

Official study title

Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.