Promoting Safe Use of Pediatric Liquid Medications

NCT01854151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2024-05-17

No results posted yet for this study

Summary

Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events, especially in the context of low health literacy. This is a particularly important issue in pediatrics as more than half of US children are exposed to one or more outpatient medications in a given week, and studies suggest that over half of caregivers make errors when dosing liquid medications for children. Our study objective is to identify evidence-based strategies for labeling and dosing prescription and over-the-counter pediatric liquid medications in order to promote safe, appropriate use, as well as to inform state and federal policy standards. We hypothesize that a health literacy-informed labeling and dosing strategy will result in improved parent ability to administer medications prescribed to their young children.

Conditions

  • Medication Errors

Interventions

OTHER

New Labeling/Dosing Strategy

Parents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Emory University

    collaborator OTHER
  • Northwestern University

    collaborator OTHER
  • Stanford University

    collaborator OTHER
  • NYU Langone Health

    lead OTHER

Principal Investigators

  • H. Shonna Yin, MD, MS · NYU School of Medicine / Bellevue Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-22
Primary Completion
2019-03-25
Completion
2019-03-25

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01854151 on ClinicalTrials.gov