Recruiting

Pediatric Medications

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT01286519

Conditions

Off Label Use of Medications in Pediatric Patients

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Off Label Use of Medications in Pediatric Patients

Study ID

NCT01286519

Start date

Jul, 2010

Status verified date

Jun, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Sneha Makhijani, BS

(984) 974-7865sneha_makhijani@med.unc.edu

Locations

University of North Carolina NC Children's Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Sneha Makhijani, MS, RN

984-974-7865sneha_makhijani@med.unc.edu

Principal Investigator:

Matthew M Laughon, MD, MPH

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-07-01.