Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

This study is currently recruiting participants.
Verified September 2013 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01481207
First received: November 21, 2011
Last updated: February 13, 2014
Last verified: September 2013
  Purpose

Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is thought to affect approximately 0.2% of live births, and is associated with a high risk of mortality or long-term neurological disability.

Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely important both for clinical management and the evaluation of therapeutic approaches. According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome following HIE. However, for various technical reasons standard MRS methods do not offer optimal sensitivity for detecting lactate, which may potentially be improved with a custom lactate editing MRS sequence. In addition, while perfusion has also been suggested as a potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has not been evaluated in comparison with more established MR biomarkers. The aims of this study are:

  1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence (specialist software) relative to the standard point resolved (PRESS) MRS sequence for detecting lactate in neonates with suspected HIE.
  2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to MRS measures as predictors of neuro-developmental outcome at 2 years.

Condition
Hypoxic Ischemic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary end-point will be reached when lactate and perfusion data have been collected from 30 neonates. The efficacy of the custom-MRS lactate editing sequence will be assessed relative to that of the standard MRS sequence for the detection of lactate (by comparing the lactate concentration (in mM) measured from the lactate edited MR spectra to that measured from the standard MR spectra).


Secondary Outcome Measures:
  • prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The secondary end-point will be reached upon completion of a neurological development assessment at the age of 2 years. Patients will be classified as having a good or poor outcome based on their motor skills at age 2, and the prognostic accuracy (eg sensitivity and specificity for predicting neuromotor outcome) of the standard and new MRI and MRS sequences will be assessed.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
neonates with perinatal asphyxia
neonates with suspected perinatal asphyxia (HIE)

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

neonates with suspected hypoxic ischemic encephalopathy

Criteria

Inclusion Criteria:

  • Newborn infants (born at >36 weeks) with suspected perinatal asphyxia. Written informed consent from both parents.

Exclusion Criteria:

  • Prematurity (born at < 36 weeks). Lack of written informed consent from both parents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481207

Contacts
Contact: Ruth L OGorman, PhD +41 44 266 7356 ruth.ogorman@kispi.uzh.ch

Locations
Switzerland
University Children's Hospital Zurich, MRI Center Recruiting
Zürich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Ruth L O'Gorman, phD University Children's Hospital Zurich, MRI Center
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01481207     History of Changes
Other Study ID Numbers: CIV-11-11-002981
Study First Received: November 21, 2011
Last Updated: February 13, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
magnetic resonance spectroscopy
magnetic resonance imaging

Additional relevant MeSH terms:
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on April 17, 2014