Efficacy of Flow Restrictors in Limiting Access of Liquid Medicines by Young Children
1 other identifier
interventional
120
0 countries
N/A
Brief 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 traditional bottles without flow restrictors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedApril 22, 2025
April 1, 2025
1 month
April 18, 2013
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
0 days
Secondary Outcomes (4)
Time required to empty the bottles
0 days
Proportion of liquid removed from bottles
0 days
Approaches used to remove liquid from bottles
0 days
Differences in proportions of children who removed specified amounts of liquid by age, sex, and site
0 days
Other Outcomes (1)
Amount of test liquid removed from individual FR-bottle designs
0 days
Study Arms (2)
Bottle with a flow restrictor
EXPERIMENTALBottle with 1 of 3 randomly assigned flow restrictor designs (FR-bottle)
Control bottle
ACTIVE COMPARATORTraditional bottle either no cap or an incompletely-closed child-resistant cap
Interventions
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.
Traditional bottle either no cap or an incompletely-closed child-resistant cap
Eligibility Criteria
You may qualify if:
- Attends one of the participating preschools
- Is between 36 - 59 months of age
- Is an English speaker
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centers for Disease Control and Preventionlead
- Grady Health Systemcollaborator
- Emory Universitycollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S Budnitz, MD, MPH
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 22, 2025
Study Start
April 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 22, 2025
Record last verified: 2025-04