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Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

This study is currently recruiting participants.
Verified February 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, 2013
Last verified: February 2013
History of Changes

November 21, 2011
February 13, 2013
November 2011
May 2014   (final data collection date for primary outcome measure)
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).
efficacy 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).
Complete list of historical versions of study NCT01481207 on ClinicalTrials.gov Archive Site
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.
Same as current
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Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

neonates with suspected hypoxic ischemic encephalopathy
Hypoxic Ischemic Encephalopathy
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neonates with perinatal asphyxia
neonates with suspected perinatal asphyxia (HIE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
up to 2 Weeks
No
Contact: Ruth L OGorman, PhD +41 44 266 7356 ruth.ogorman@kispi.uzh.ch
Switzerland
 
NCT01481207
CIV-11-11-002981
No
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Ruth L O'Gorman, phD University Children's Hospital Zurich, MRI Center
University Children's Hospital, Zurich
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP