Status:
COMPLETED
COA-APTIC Caregiver Concept Elicitation Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Pain Measurement
Eligibility:
All Genders
18+ years
Brief Summary
This is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.
Detailed Description
The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. Study tea...
Eligibility Criteria
Inclusion
- Cares for a child who is both:
- Between 0 and \<3 years of age
- Experiencing or has experienced acute pain in one of the following categories:
- Malignant or non-malignant visceral or hematologic disease
- Surgery (or other procedure)
- Trauma or injury
- Congenital conditions
- Is over the age of 18 years old.
- Can speak and understand English.
- Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.
Exclusion
- Lack of access to a telephone or computer for interview
- Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.
Key Trial Info
Start Date :
June 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04392180
Start Date
June 23 2021
End Date
April 26 2022
Last Update
June 9 2022
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27701