Enhanced Child-safety PackagingNCT06938620
Efficacy of Flow Restrictors in Limiting Access of Liquid Medicines by Young Children
A study testing Bottle with a flow restrictor in people with Enhanced Child-safety Packaging, run by Centers for Disease Control and Prevention.
Trial summary
This study aimed to assess whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, affects the proportion of preschool-aged children who can access liquid bottle contents, the amount accessed, and the time required for children to empty the bottles compared with… Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Enhanced Child-safety Packaging
- What is being tested?
- Bottle with a flow restrictor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to May 2012
- Phase
- Interventional
- 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 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attends one of the participating preschools
- Is between 36 - 59 months of age
- Is an English speaker
Who cannot join
- Has an obvious or overt, temporary or permanent, injury, illness, or physical or mental disability
- Has known allergies/restrictions to ingesting any ingredients in the test liquid
About this study
This study aimed to assess whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, affects the proportion of preschool-aged children who can access liquid bottle contents, the amount accessed, and the time required for children to empty the bottles compared with traditional bottles without flow restrictors.
Read the detailed description
Unsupervised ingestion of medications by young children is an important public health concern, leading to tens of thousands of emergency department visits and many more calls to poison control centers each year. Current knowledge on the specific circumstances in which young children gain access to medications is limited; however, a number of studies have shown that improper replacement of child-resistant packaging (CRP) by a caregiver leads to a substantial number of these incidents. Beginning in 2011, several pharmaceutical manufacturers introduced flow restrictors on over-the-counter (OTC) infants' acetaminophen; however, the efficacy of flow restrictors in limiting accessibility of liquid medicines by young children has not been formally assessed.
This study sought to determine whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, to liquid medicine bottles can provide additional protection against unsupervised medicine ingestions by young children. A modified version of the standard child test protocol for re-closeable packages outlined in the Poison Prevention Packaging Act (PPPA protocol) was used to assess the efficacy of flow restrictors in limiting children's access to liquid medicines. Preschool-aged children participated in two 10-minute trials in which they were asked to try to "get everything out" of bottles filled with test liquid (a food product with similar flow characteristics to liquid medicine). Randomized block design was used to assign specific bottles to participants. Each child tested an uncapped bottle with a flow restrictor (FR-bottle) for one trial (1 of 3 designs randomly assigned). For the other trial, the child tested a control bottle (a traditional bottle either no cap or an incompletely-closed child-resistant cap). The amount of liquid the child removed from each bottle was measured and the time required to empty bottles was recorded. If flow restrictors limit the amount of liquid a young child can access, even when the outer child-resistant cap is not fully secured, their use could potentially be expanded to other liquid medicines.
- Conditions
- Enhanced Child-safety Packaging
- Being tested
- Bottle with a flow restrictor, Control bottle
- Keywords
- Child Injury, Child-resistant Packaging, Pediatric Poisoning, Medication Safety, Injury Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle with a flow restrictorOther
Flow restrictors added to liquid medicine bottles to determine whether they limit accessibility of liquid bottle contents to young children compared with control bottles without flow restrictors.
Control bottleOther
Traditional bottle either no cap or an incompletely-closed child-resistant cap
| Study group | Role | What they receive |
|---|---|---|
| Bottle with a flow restrictor | Experimental | Bottle with 1 of 3 randomly assigned flow restrictor designs (FR-bottle) Receives: Other: Bottle with a flow restrictor |
| Control bottle | Active comparator | Traditional bottle either no cap or an incompletely-closed child-resistant cap Receives: Other: Control bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children who removed specified amounts of test liquid from FR-bottles compared with control bottles
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
Measured: 0 days
Secondary outcomes (4)
Time required to empty the bottles
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
Measured: 0 days
Proportion of liquid removed from bottles
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
Measured: 0 days
Approaches used to remove liquid from bottles
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
Measured: 0 days
Differences in proportions of children who removed specified amounts of liquid by age, sex, and site
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Child-safety PackagingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Grady Health System, Emory University
- Responsible party
- Sponsor
- Investigators
- Daniel S Budnitz, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938620
- Sponsor's protocol ID
- CDC-NCEZID-6162
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2013
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flow Restrictors in Limiting Access of Liquid Medicines by Young Children
- ClinicalTrials.gov ID
- NCT06938620
- Acronym / sponsor ID
- CDC-NCEZID-6162
- Conditions
- Enhanced Child-safety Packaging
- Keywords
- Child Injury, Child-resistant Packaging, Pediatric Poisoning, Medication Safety, Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Grady Health System, Emory University
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Apr 2025 (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.
This study aimed to assess whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, affects the proportion of preschool-aged children who can access liquid bottle contents, the amount accessed, and the time required for children to empty the bottles compared with traditional bottles without flow restrictors.
Detailed description
Unsupervised ingestion of medications by young children is an important public health concern, leading to tens of thousands of emergency department visits and many more calls to poison control centers each year. Current knowledge on the specific circumstances in which young children gain access to medications is limited; however, a number of studies have shown that improper replacement of child-resistant packaging (CRP) by a caregiver leads to a substantial number of these incidents. Beginning in 2011, several pharmaceutical manufacturers introduced flow restrictors on over-the-counter (OTC) infants' acetaminophen; however, the efficacy of flow restrictors in limiting accessibility of liquid medicines by young children has not been formally assessed.
This study sought to determine whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, to liquid medicine bottles can provide additional protection against unsupervised medicine ingestions by young children. A modified version of the standard child test protocol for re-closeable packages outlined in the Poison Prevention Packaging Act (PPPA protocol) was used to assess the efficacy of flow restrictors in limiting children's access to liquid medicines. Preschool-aged children participated in two 10-minute trials in which they were asked to try to "get everything out" of bottles filled with test liquid (a food product with similar flow characteristics to liquid medicine). Randomized block design was used to assign specific bottles to participants. Each child tested an uncapped bottle with a flow restrictor (FR-bottle) for one trial (1 of 3 designs randomly assigned). For the other trial, the child tested a control bottle (a traditional bottle either no cap or an incompletely-closed child-resistant cap). The amount of liquid the child removed from each bottle was measured and the time required to empty bottles was recorded. If flow restrictors limit the amount of liquid a young child can access, even when the outer child-resistant cap is not fully secured, their use could potentially be expanded to other liquid medicines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bottle with a flow restrictor | Experimental | Other: Bottle with a flow restrictorBottle with 1 of 3 randomly assigned flow restrictor designs (FR-bottle) |
| Control bottle | Active comparator | Other: Control bottleTraditional bottle either no cap or an incompletely-closed child-resistant cap |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Attends one of the participating preschools
- Is between 36 - 59 months of age
- Is an English speaker
Key exclusion criteria (2 listed)
- Has an obvious or overt, temporary or permanent, injury, illness, or physical or mental disability
- Has known allergies/restrictions to ingesting any ingredients in the test liquid
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 |
|---|---|---|
| Bottle with a flow restrictorFlow restrictors added to liquid medicine bottles to determine whether they limit accessibility of liquid bottle contents to young children compared with control bottles without flow restrictors. | Other | Bottle with a flow restrictor |
| Control bottleTraditional bottle either no cap or an incompletely-closed child-resistant cap | Other | Control bottle |
Primary outcome
Proportion of children who removed specified amounts of test liquid from FR-bottles compared with control bottles
Time frame: 0 days
Proportion of children who emptied bottles, removed ≥ 25 mL, and who removed ≥ 5 mL of liquid from FR-bottles compared with control bottles
4 secondary outcomes
Time required to empty the bottles
Time frame: 0 days
Proportion of liquid removed from bottles
Time frame: 0 days
Approaches used to remove liquid from bottles
Time frame: 0 days
Differences in proportions of children who removed specified amounts of liquid by age, sex, and site
Time frame: 0 days
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 22 Apr 2025.
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.
Daniel S Budnitz, MD, MPH principal investigator
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A study testing Bottle with a flow restrictor in people with Enhanced Child-safety Packaging, run by Centers for Disease Control and Prevention.
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 3 inclusion and 2 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 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 children who removed specified amounts of test liquid from FR-bottles compared with control bottles (time frame: 0 days). 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 22 Apr 2025.