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Completed

NCT Number: NCT02529202

Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 hour–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Seattle Children's Hospital

Seattle, Washington, 98015, United States

About this study

The goal of this proposal is to determine the pharmacokinetics (PK) of dexmedetomidine (DEX) in newborns in the neonatal intensive care unit (NICU) receiving therapeutic hypothermia (TH) for moderate to severe hypoxic-ischemic encephalopathy (HIE). In newborns with HIE, TH for 72 hours is the standard therapy to mitigate brain damage. Most HIE patients receive mechanical ventilation during TH and are thus sedated with morphine. Unfortunately, morphine has negative side effects and does not specifically prevent shivering. Prevention of shivering is critical to success of TH, as shivering negates cooling. DEX is a particularly promising alternative sedative because it does prevent shivering and is already used in NICUs for sedation and pain management. In newborns, DEX PK data in the setting of TH is not available and needs to be determined to properly dose DEX for HIE patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine infusion

Other names: Precedex

Primary outcomes

  1. Pharmacokinetic (PK) parameter of area under the curve (AUC)

    Time frame: Day 1 to Day 4

    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.

  2. Pharmacokinetic (PK) parameter of clearance

    Time frame: Day 1 to Day 4

    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.

  3. Pharmacokinetic (PK) parameter of terminal half-life

    Time frame: Day 1 to Day 4

    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.

  4. Pharmacokinetic (PK) of volume of distribution

    Time frame: Day 1 to Day 4

    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.

Secondary outcomes

  1. Efficacy of dexmedetomidine at preventing shivering

    Time frame: Day 1 to Day 3

    Measure number of morphine doses given for shivering in neonates receiving a continuous dexmedetomidine infusion during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

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

    Time frame: Day 1 to Day 4

    Safety assessments will include: adverse events, physical examination findings, vital signs including continuous heart rate, blood pressure, respiratory rate, and pulse oximetry monitoring in neonates receiving a continuous dexmedetomidine infusion during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Dexmedetomidine Use During Therapeutic Hypothermia Treatment for Neonates With Hypoxic-ischemic Encephalopathy: The Cool DEX Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 20, 2015
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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