Clinical trial NCT03925623: Design Factors for Evaluating Child Resistant Packaging
Official title: Design Factors for Evaluating Child Resistant Packaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unintentional Injury
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 27
Sex: ALL
Minimum age (years): 42
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 42-54 months of age Recruited from preschools throughout mid Michigan

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).

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).

Eligibility 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

Primary outcomes:
measure: Proportion of successful openings within a given treatment
timeFrame: First five minutes OR Second five minutes
measure: Time to successful opening
timeFrame: First five minutes OR Second five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University Child Development Laboratory- East Lansing
state: Michigan
city: East Lansing
country: United States
facility: School of Packaging
state: Michigan
city: Haslett
country: United States
facility: Wilkshire Early Childhood Center-
state: Michigan
Study officials:
References: