Clinical Trials Logo

Clinical Trial Summary

This is an open-label, non-randomized crossover design feasibility trial comparing oral hydrocortisone treatment with interval bolus delivery (pulsatile) of subcutaneous hydrocortisone via infusion pump in children with congenital adrenal hyperplasia. Eight children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic profiles of cortisol, 17-hydroxyprogesterone and androstenedione concentrations while on oral hydrocortisone therapy (admission 1), during an initial trial of the subcutaneous hydrocortisone pump (admission 2), and after 6 weeks of subcutaneous hydrocortisone pump treatment (admission 3). An integrated pharmacokinetic and pharmacodynamic model will be used to determine cortisol, 17-hydroxyprogesterone and androstenedione parameters to compare the duration of time subjects have these concentrations outside acceptable ranges. Funding Source - FDA OOPD


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03718234
Study type Interventional
Source University of Minnesota
Contact
Status Completed
Phase Phase 1
Start date January 1, 2019
Completion date February 23, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Not yet recruiting NCT03291678 - Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy N/A
Completed NCT00489788 - Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI N/A
Terminated NCT00268060 - Infant Medical Records: Case Report Proposal N/A
Not yet recruiting NCT05955794 - Vocal Pattern Assessment as a New Key to Identifying Rare Syndromes N/A
Completed NCT00257517 - Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle N/A
Completed NCT00478296 - Pulmonary Hypertension in Trisomy 21 Patients N/A
Completed NCT04556487 - Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Terminated NCT00261989 - Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD N/A
Completed NCT00211081 - Spironolactone in Patients With Single Ventricle Heart N/A
Terminated NCT00268099 - Optimal Timing for Repair of Right-to-Left Shunt Lesions N/A
Active, not recruiting NCT05752019 - TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
Completed NCT00490295 - Biomarkers for Detection of Brain Ischemia N/A
Terminated NCT00327899 - Home Inotropic Therapy in Children N/A
Terminated NCT00229905 - Child With Anomalous Drainage of IVC to Left Atrium N/A
Completed NCT00277901 - MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation N/A
Terminated NCT00366314 - Frequency of Accessing Central Lines for Blood Samples N/A
Terminated NCT00268034 - Left Ventricular Aneurysms in Children N/A
Completed NCT00366847 - Computer Modeling of Congenital Heart Disease N/A
Withdrawn NCT00460824 - A Retrospective Review - Anti-HLA Antibodies N/A