Automated Harness Tightener for Child Safety Seat

NCT04408417 | Completed

• 2 other identifiers: 19-016821R44HD085660
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to evaluate the efficacy of a tensioning progress indicator light to achieve proper harness tensioning in child safety seats.

Conditions

Child Passenger Safety

Outcome Measures

Primary Outcomes (1)

• Change in harness tension

  After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative "pinch" test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared.

  Up to 5 minutes

Secondary Outcomes (1)

• Participant perceptions of usability of the tension progress indicator light technology: survey

  30 minutes

Study Arms (4)

Harnessing Sequence A

EXPERIMENTAL

Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.

Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

Harnessing Sequence B

EXPERIMENTAL

Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.

Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

Harnessing Sequence C

EXPERIMENTAL

Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.

Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

Harnessing Sequence D

EXPERIMENTAL

Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.

Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

Interventions

Prototype child safety seat with tension indicator lights DEVICE

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Harnessing Sequence A; Harnessing Sequence B; Harnessing Sequence C; Harnessing Sequence D

Control child safety seat DEVICE

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Harnessing Sequence A; Harnessing Sequence B; Harnessing Sequence C; Harnessing Sequence D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years who are the parent/legal guardian of a child aged 6 months-24 months
• Parent/legal guardian has harnessed a child into a safety seat in the last 30 days

You may not qualify if:

• Non-fluency in written and/or spoken English
• Parent/legal guardian cannot install, and/or child cannot be harnessed into, a safety seat due to a physical or health limitation

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Minnesota HealthSolutions: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Philadelphia, Pennsylvania, 19146, United States

Location

Study Officials

• Allison Curry, PhD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Nick Rydberg

  Minnesota HealthSolutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 29, 2020
• Study Start: March 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.
• Access Criteria: IRB approval, data use agreement

Locations

US (1)