University of North Carolina NC Children's Hospital
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
Location contact
Matthew M Laughon, MD, MPH
PRINCIPAL_INVESTIGATOR
Sneha Makhijani, MS, RN
CONTACT
Recruiting
NCT Number: NCT01286519
Pharmacokinetics of Off Label Pediatric Medications
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
Recruiting
Interested in participating?
Request InfoKey information
Age range
1 day–8 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Area under the curve (AUC)
Time frame: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.
actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug.
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Volume of distribution at steady-state
Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
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Terminal elimination rate constant (Ke) and Half-Life
Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.
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Plasma Clearance
Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
the rate at which the drug is eliminated from the body divided by the plasma concentration.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of North Carolina, Chapel Hill
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2035
- Study completion
- 2035
- First posted
- Jan 31, 2011
- Registry last updated
- Jul 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.