Clinical trial NCT01481207: Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Official title: Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: magnetic resonance spectroscopy
magnetic resonance imaging
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 59
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates with suspected hypoxic ischemic encephalopathy

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.


Eligibility 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.

Primary outcomes:
measure: sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence.
timeFrame: 12 months
Secondary outcomes:
measure: prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2
timeFrame: 3 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich, MRI Center
Study officials:
affiliation: University Children's Hospital Zurich, MRI Center
name: Ruth L O'Gorman, phD
role: PRINCIPAL_INVESTIGATOR
References: