Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Treatments: Adrenergic alpha-2 Receptor Agonists; Central Nervous System Depressants; Dexmedetomidine

Criteria

Inclusion Criteria:

1. 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.

2. Cooled infants who are initially intubated and mechanically ventilated.

3. Infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering.

4. 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).

Exclusion Criteria:

1. Known chromosomal anomalies.

2. Newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line.

3. Patients with known cyanotic congenital heart defects

4. Patients who are participating in another clinical trial.

5. Patients who received DEX prior to enrollment in the study

6. At the discretion of the Investigator, subjects in whom the risk of Dexmedetomidine treatment is expected to exceed its benefits.