Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

NCT02529202 | Completed Early Phase 1 DMC

• 1 other identifier: 15647
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxic-ischemic Encephalopathy

Keywords

Dexmedetomidine; Neonate; Pharmacokinetics; Therapeutic Hypothermia; Hypoxic-ischemic Encephalopathy; Adrenergic Agents; Adrenergic Agonists; Analgesics; Adrenergic alpha-2 Receptor Agonists; Central Nervous System Agents; Central Nervous System Depressants

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic (PK) parameter of area under the curve (AUC)

  Estimate PK parameter of AUC in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.

  Day 1 to Day 4

• Pharmacokinetic (PK) parameter of clearance

  Estimate PK parameter of clearance in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.

  Day 1 to Day 4

• Pharmacokinetic (PK) parameter of terminal half-life

  Estimate PK parameter of terminal half-life in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.

  Day 1 to Day 4

• Pharmacokinetic (PK) of volume of distribution

  Estimate PK parameter of volume of distribution in newborns ≥36 weeks post-menstrual age with hypoxic-ischemic encephalopathy treated with a continuous dexmedetomidine infusion during therapeutic hypothermia.

  Day 1 to Day 4

Secondary Outcomes (2)

• Efficacy of dexmedetomidine at preventing shivering

  Day 1 to Day 3

• Safety of dexmedetomidine in neonatal subjects. (composite outcome will include: adverse events, physical examination findings, and vital signs)

  Day 1 to Day 4

Study Arms (1)

Dexmedetomidine group

EXPERIMENTAL

Neonates with hypoxic-ischemic encephalopathy will receive a dexmedetomidine maintenance infusion of 0.4 mcg/kg/hr during treatment with therapeutic hypothermia and during re-warming (78 hours total).

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion

Also known as: Precedex

Dexmedetomidine group

Eligibility Criteria

• Age: 1 Hour - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98015, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ryan M McAdams, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Neonatologist

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 20, 2015
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)