An observational study in Hypoxic Ischemic Encephalopathy, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged Up to 2 Weeks. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by University Children's Hospital, Zurich · Observational
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:
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neonates with suspected hypoxic ischemic encephalopathy
Exclusion Criteria:
neonates with suspected perinatal asphyxia (HIE)
sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence.
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).
Time frame: 12 months
prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2
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.
Time frame: 3 years
Plan to share: No
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University Children's Hospital, Zurich