Actively Recruiting
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Led by Duke University · Updated on 2025-09-09
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).
CONDITIONS
Official Title
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver of a child between 0 and less than 2 years old who is experiencing or has experienced acute pain in the past four weeks from malignant or non-malignant visceral or hematologic disease, surgery or other procedure, trauma or injury, or congenital conditions
- Over 18 years old
- Able to speak and understand English or Spanish
- Willing and able to provide informed consent and allow medical record review
- Clinician currently practicing in a clinical care environment
- Treats pediatric patients aged 0 to less than 2 years for acute pain
- Spends more than 50% of clinical time caring for pediatric patients
- Holds a position as a physician, clinical pharmacist (Pharm D), nurse practitioner, physician assistant, or nurse (BSN/RN or higher)
- Able to speak and understand English
- Willing and able to provide informed consent for interview participation
You will not qualify if you...
- Lack of access to a telephone or computer for interview participation
- For caregivers, child is premature at less than 32 weeks corrected gestational age at enrollment with no other eligible child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701
Actively Recruiting
Research Team
S
Sophie Wang, MBBS, MHS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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