Measuring how off-label medications affect children
Official title: Pharmacokinetics of Off Label Pediatric Medications
Run by University of North Carolina, Chapel Hill · NCT01286519 · Data updated 2026-11-12
This study is testing how off-label medications affect young children by looking at drug levels in their blood and other fluids to better understand their safety and effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 8 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | July 2010 |
| Main results expected | December 2035 |
| Study ends | December 2035 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT01286519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under 8 years old who are receiving medications not currently approved by the FDA for their specific use.
✕Probably not a fit
Patients who do not provide consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the pharmacokinetics of medications used off-label in pediatric patients by analyzing levels of these drugs in body fluids such as blood, urine, and spinal fluid. It addresses the significant gap in safety and efficacy data for therapeutic agents in children under 8 years of age. The study utilizes scavenged samples, which are extra fluids collected during routine medical tests, to gather necessary data without additional procedures. This observational approach allows for the collection of real-world data on medication effects in a vulnerable population.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how off-label medications work in children, leading to safer and more effective treatments.
How similar studies have gone: While there is limited data on similar studies, the approach of using scavenged samples for pharmacokinetic analysis in pediatric populations is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children less than 8 years of age * Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care Exclusion Criteria: * Lack of consent
Where it's running
-
University of North Carolina NC Children's Hospital
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Matthew M. Laughon, MD, MPH — University of North Carolina
- Study coordinator: Sneha Makhijani, BS
- Email: sneha_makhijani@med.unc.edu
- Phone: (984) 974-7865
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.