Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

NCT01481207 | Completed

• 1 other identifier: CIV-11-11-002981
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

magnetic resonance spectroscopy; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (1)

• prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2

  3 years

Study Arms (1)

neonates with perinatal asphyxia

neonates with suspected perinatal asphyxia (HIE)

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

neonates with suspected hypoxic ischemic encephalopathy

You may qualify if:

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

You may not qualify if:

• Prematurity (born at \< 36 weeks). Lack of written informed consent from both parents.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich, MRI Center

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth L O'Gorman, phD

  University Children's Hospital Zurich, MRI Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 29, 2011
• Study Start: September 1, 2011
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)