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Efficacy of Flow Restrictors in Limiting Access of Liquid Medicines by Young Children

NCT06938620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-22

No results posted yet for this study

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.

Conditions

  • Enhanced Child-safety Packaging

Interventions

OTHER

Bottle with a flow restrictor

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.

OTHER

Control bottle

Traditional bottle either no cap or an incompletely-closed child-resistant cap

Sponsors & Collaborators

Principal Investigators

  • Daniel S Budnitz, MD, MPH · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
36 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938620 on ClinicalTrials.gov