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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Design Factors for Evaluating Child Resistant Packaging

Clinicaltrials.gov identifier NCT03925623

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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

  • Condition or Disease:Unintentional Injury
  • Intervention/Treatment: Other: Novel approaches for the design of child resistant closures
  • Phase: N/A
Detailed Description

In order to evaluate the effectiveness of cognitive and physical barriers as child resistant design features, we are testing designs which change the physical area available for grip utilizing anthropometric data that, in theory, would exclude children and enable adults. Testing will be conducted with children aged between 42-54 months of age. Our testing is adapted from testing dictated by 16 CFR 1700; this testing is mandated by the Poison Prevention Packaging Act of 1970 and is used throughout the United States (and, in fact, adapted by much of the world) to verify the performance of child resistant packaging. The maximum age limit specified by 16 CFR 1700 is 51 months so the child testing for this study represents a more severe test of the closure. One type of package is being tested: a 38mm diameter neck 400 thread finish (38/400) bottle that is typical of what is used to hold over-the-counter (OTC) medications. The bottle is outfitted with a two-piece continuous thread screw cap closure. Three treatments of the screw cap are being evaluated. One treatment attempts to restrict children from accessing the package using a cognitive paradigm (design intuitiveness for opening) the second treatment leverages a physical paradigm (anthropometric characteristics of the hand to keep them out) and the third treatment, the control, is a standard OTC push-down and turn child resistant screw cap. Summary Children will be recruited with the help of the Michigan State University Child Development Labs (MSU CDL) and testing will take place in a designated room within the Wilkshire Early Childhood Center in Haslett, Michigan and/or Early Learning Institute (ELI) preschool in East Lansing, MI. Approximately 120 children will test a single treatment of the three (N=40 per treatment); attempts will be made to counterbalance age and sex by treatment . The width of each child's thumbs will be measured by taking a digital photographic with their hand place on a grid of known dimensions. Testing will then occur in two 5 minute segments for each treatment (as with the regulated protocol overseen by CPSC).

Study Design
  • Study Type: Observational
  • Actual Enrollment: 27 participants
  • Observational Model: Other
  • Time Perspective: Other
  • Official Title: Design Factors for Evaluating Child Resistant Packaging
  • Actual Study Start Date: December 2017
  • Actual Primary Completion Date: April 2018
  • Actual Study Completion Date: September 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Cognitively based design strategy
Participants (42-54 months of age) will be assigned to try to open one of three treatments. One cohort will receive a 38/400 bottle equipped with the design feature that was introduced as part of the physical intervention (above); however, this treatment is sized such that children should be able to engage it (if they understand how). In having these three treatments, we began to evaluate the paradigm which enables the design to work. (Do they fail to understand how?- Cognitive treatment fail- and or Can they not effectively manipulate the closure? --- Physical failure).
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.
: Commercial closure system
Participants (42-54 months of age) will be assigned to try to open one of three treatments. One cohort will receive a 38/400 bottle equipped with a standard two piece push and turn cap and asked to open this during 2 five minute trials.
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.
: Physically based design strategy
Participants (42-54 months of age) will be assigned to try to open one of three treatments. One cohort will receive a 38/400 bottle equipped a novel closure that was designed using anthropometric data such that it disallows children from engaging the system and enables adults. Children will be asked to open this during 2 five minute trials.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Proportion of successful openings within a given treatment [ Time Frame: First five minutes OR Second five minutes ]
    Openings are recorded in binary fashion (child was successful yes/no)
  • 2. Time to successful opening [ Time Frame: First five minutes OR Second five minutes ]
    The time it took for children to successfully open the packaging
Eligibility Criteria
  • Ages Eligible for Study: 42 to 54 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: 42-54 months of age Recruited from preschools throughout mid Michigan
Criteria

Inclusion Criteria:

- Be aged between 42 months to 54 months at the time of testing Have IRB approved
consent form signed by parent or guardian Haver permission to be video taped Provide
verbal assent (or assent through body language- head nod, etc)

Exclusion Criteria:

- No history of food allergies of any kind

- No known issues with lactose, including lactose intolerance or allergy

- Have no physical or mental impairments that impact their ability to open packages

Contacts and Locations
Contacts
Locations

United States, Michigan
Michigan State University Child Development Laboratory- East Lansing
East Lansing

United States, Michigan
School of Packaging
East Lansing

United States, Michigan
Wilkshire Early Childhood Center-
Haslett

Sponsors and Collaborators

Michigan State University

More Information
  • Responsible Party: Michigan State University
  • ClinicalTrials.gov Identifier: NCT03925623 History of Changes
  • Other Study ID Numbers: MSU17-1447
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Raw flat file will be available deidentified. Not even the research team will be able to tie data to subject identity
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
  • Time Frame: June 2019
  • Access Criteria: Will be provided with publications as a deidentified flat file as required by editors
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No