Measuring how off-label medications affect children
Pharmacokinetics of Off Label Pediatric Medications
University of North Carolina, Chapel Hill · NCT01286519
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 1 Day to 8 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT01286519 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not provide consent will not benefit from this study.
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 performed: While there is limited data on similar studies, the approach of using scavenged samples for pharmacokinetic analysis in pediatric populations is relatively novel.
Eligibility criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Off Label Use of Medications in Pediatric Patients, pharmacokinetics