Pharmacokinetics of Off Label Pediatric Medications



Status:Recruiting
Healthy:No
Age Range:Any - 8
Updated:10/24/2018
Start Date:July 2010
End Date:December 2022
Contact:Jennifer Talbert, MS, RN
Email:jtalbert@med.unc.edu
Phone:(984) 974-7865

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The purpose of this study is to measure the level of medicines found in body fluids such as
blood, urine, spinal fluid of children.

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.

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
We found this trial at
1
site
Chapel Hill, North Carolina 27514
Principal Investigator: Matthew M Laughon, MD, MPH
Phone: 984-974-7865
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mi
from
Chapel Hill, NC
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