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Clinical Trial Summary

The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.


Clinical Trial Description

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication. ;


Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00576381
Study type Interventional
Source Children's Hospital of Philadelphia
Contact
Status Completed
Phase Phase 1
Start date April 2006
Completion date December 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04106479 - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Completed NCT00573066 - Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery Phase 1
Completed NCT03678909 - Cardiac Biomarkers in Patients With Single Ventricle Physiology
Terminated NCT04090697 - Use of Oxandrolone to Promote Growth in Infants With HLHS Phase 1/Phase 2
Completed NCT00166101 - NIRS in Neonatal Cardiac Surgery N/A