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Design Factors for Evaluating Child Resistant Packaging

NCT03925623 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2024-05-03

No results posted yet for this study

Summary

Each year over 59,000 children under the age of 5 are taken to emergency rooms (equivalent to 4 busloads of children arriving every day to the ER) because they were able to get into medication containers unsupervised. 95 percent of these ER visits occurred due to the child getting into medicine when an adult was not looking.

Child resistant containers (CRC) are intended to restrict entry by imposing a cognitive barrier (the child must understand how to operate the CRC mechanism in order to open it) and a physical barrier (the child must posses the motor skills necessary to operate the CRC).

Investigators are testing a design which changes the physical area available for grip utilizing anthropometric data that, in theory, would exclude children and enable adults.

Investigators will evaluate the proposed design's effectiveness in two ways (1: cognitive barrier) will the child understand where they need to specifically grip the cap with their fingers and (2: physical barrier) will the child be able to use an appropriate gripping strategy to apply enough torque to rotate the cap and open it.

Conditions

  • Unintentional Injury

Interventions

OTHER

Novel approaches for the design of child resistant closures

Two novel designs for child resistant closures are tested. One is sized based on the anthropometric properties of adults and children's hands such that it should disallow children from engaging the system and enable adults (the physically based design strategy). The other replicates the first design, but is sized such that either of the two populations should be able to engage the closure. In testing this way, we begin to differentiate the paradigm that holds the children out (the cognitively based design strategy-- they do not understand and/or a physical one- they are unable to use the closure). Results (proportion of children opening within the first or second five minute periods of test and time to opening during the same) from each of these, will be compared to results from the third treatment, a standard, commercially available push and turn system.

Sponsors & Collaborators

Eligibility

Min Age
42 Months
Max Age
54 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2018-04-25
Completion
2018-09-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925623 on ClinicalTrials.gov