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NCT05552027

Minnesota HealthSolutions Cellular Car Seat Study

Completed Phase 2 Results posted Last updated 19 September 2024
What this trial tests

Phase 2 trial testing CCS System- Prototype in Child Safety Seat Harness Tension in 92 participants. Completed in 17 November 2022.

Timeline
15 June 2022
Primary endpoint
17 November 2022
17 November 2022

Quick facts

Lead sponsorMinnesota HealthSolutions
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment92
Start date15 June 2022
Primary completion17 November 2022
Estimated completion17 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Minnesota HealthSolutions

Who can join

Adults 18 to 75, any sex, with Child Safety Seat Harness Tension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Installation Errors Primary · 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).

GroupValue95% CI
Intervention - Scenario A21
Control - Scenario A41
Intervention - Scenario B17
Control - Scenario B32
Intervention - Scenario C18
Control - Scenario C33

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Minnesota HealthSolutions trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05552027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing