An interventional study of Prototype child safety seat with tension indicator lights and Control child safety seat in Child Passenger Safety, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
The primary objective of the study is to determine whether a prototype convertible child safety seat with visual indication of successful tensioning technology reduces the amount of harness slack compared with a standard safety seat. The secondary objective of the study is to assess caregivers' perceptions of the quality, design, and ease of use of the prototype child safety seat tensioning progress indicator lights. Participants will be parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age. Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to harness their child into two versions of a convertible child safety seat, twice in each car seat. The intervention seat will be equipped with the technology that gives visual indication of successful harness tensioning. Participants will be observed, assessed, and asked a series of survey questions after each harnessing period.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.
The control child safety seat is a convertible rear-facing seat without tension indicator lights.
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.
Time frame: Up to 5 minutes
Participant perceptions of usability of the tension progress indicator light technology: survey
Participant perceptions of the usability of the technology will be collected and the control and prototype harnessing systems will be compared. Participants will be asked to complete a post-intervention survey that contains 4 items pertaining to the usability of the technology through Likert scales (range from Very difficult to Very easy). There is no overall score for these survey items.
Time frame: 30 minutes
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia