Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03925623
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2019-04-19
Brief Title:
Design Factors for Evaluating Child Resistant Packaging
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
Design Factors for Evaluating Child Resistant Packaging
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each year over 59000 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 designs 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
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 designs 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 38400 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 andor Early Learning Institute ELI preschool in East Lansing MI Approximately 120 children will test a single treatment of the three N40 per treatment attempts will be made to counterbalance age and sex by treatment The width of each childs 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
One type of package is being tested a 38mm diameter neck 400 thread finish 38400 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 andor Early Learning Institute ELI preschool in East Lansing MI Approximately 120 children will test a single treatment of the three N40 per treatment attempts will be made to counterbalance age and sex by treatment The width of each childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None