Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01481207
Recruitment Status : Recruiting
First Posted : November 29, 2011
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief Summary:

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 or disease
Hypoxic Ischemic Encephalopathy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Study Start Date : November 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

neonates with perinatal asphyxia
neonates with suspected perinatal asphyxia (HIE)

Primary Outcome Measures :
  1. sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence. [ Time Frame: 12 months ]
    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 :
  1. prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2 [ Time Frame: 3 years ]
    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.

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neonates with suspected hypoxic ischemic encephalopathy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481207

Contact: Ruth L OGorman, PhD +41 44 266 7356

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

Responsible Party: University Children's Hospital, Zurich Identifier: NCT01481207     History of Changes
Other Study ID Numbers: CIV-11-11-002981
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain