Unintentional InjuryNCT03925623
Design Factors for Evaluating Child Resistant Packaging
An observational study of Unintentional Injury, run by Michigan State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Unintentional Injury
- What is being tested?
- Novel approaches for the design of child resistant closures
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Dec 2017to 28 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 42-54 months of age Recruited from preschools throughout mid Michigan
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michigan State University Child Development Laboratory- East Lansing
East Lansing, Michigan, 48823
School of Packaging
East Lansing, Michigan, 48824
Wilkshire Early Childhood Center-
Haslett, Michigan, 48840
About this study
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).
Read more
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.
Read the detailed description
In order to evaluate the effectiveness of cognitive and physical barriers as child resistant design features, investigators 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).
- Conditions
- Unintentional Injury
- Being tested
- Novel approaches for the design of child resistant closures
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel approaches for the design of child resistant closuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Novel approaches for the design of child resistant closures | |
| 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. Receives: Other: Novel approaches for the design of child resistant closures | |
| 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). Receives: Other: Novel approaches for the design of child resistant closures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful openings within a given treatment
Openings are recorded in binary fashion (child was successful yes/no)
Measured: First five minutes OR Second five minutes
Time to successful opening
The time it took for children to successfully open the packaging
Measured: First five minutes OR Second five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start14 Dec 2017
- Primary completion25 Apr 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unintentional InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Bix, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925623
- Sponsor's protocol ID
- MSU17-1447
- Status last verified
- May 2024
- First submitted
- 19 Apr 2019
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw flat file will be available deidentified. Not even the research team will be able to tie data to subject identity
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Factors for Evaluating Child Resistant Packaging
- ClinicalTrials.gov ID
- NCT03925623
- Acronym / sponsor ID
- MSU17-1447
- Conditions
- Unintentional Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to evaluate the effectiveness of cognitive and physical barriers as child resistant design features, investigators 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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Commercial closure system | – | Other: Novel approaches for the design of child resistant closuresParticipants (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. |
| Physically based design strategy | – | Other: Novel approaches for the design of child resistant closuresParticipants (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. |
| Cognitively based design strategy | – | Other: Novel approaches for the design of child resistant closuresParticipants (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). |
Who may qualify
- Ages
- 42 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 42-54 months of age Recruited from preschools throughout mid Michigan
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel approaches for the design of child resistant closuresTwo 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. | Other | Cognitively based design strategy, Commercial closure system, Physically based design strategy |
Primary outcome
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)
Time to successful opening
Time frame: First five minutes OR Second five minutes
The time it took for children to successfully open the packaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Yes. Raw flat file will be available deidentified. Not even the research team will be able to tie data to subject identity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unintentional Injury, run by Michigan State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful openings within a given treatment (time frame: First five minutes OR Second five minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.