Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

Completed · Early Phase 1

Conditions studied: Hypoxic-ischemic Encephalopathy

In brief

The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

Key facts

Study ID

NCT02529202

Run by

Seattle Children's Hospital

People needed

7

Starts

2016-03-01

Expected to finish

2017-01-01

Last updated by the study team

2017-01-12

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborns 36 weeks gestation or older with moderate to severe hypoxic-ischemic encephalopathy identified and treated with therapeutic hypothermia in the Seattle Children's Hospital neonatal intensive care unit.
• Cooled infants who are initially intubated and mechanically ventilated.
• Infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering.
• Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

You may not qualify if…

• Known chromosomal anomalies.
• Newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line.
• Patients with known cyanotic congenital heart defects
• Patients who are participating in another clinical trial.
• Patients who received DEX prior to enrollment in the study
• At the discretion of the Investigator, subjects in whom the risk of Dexmedetomidine treatment is expected to exceed its benefits.

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.