CHU Bordeaux
Bordeaux, France
NCT Number: NCT04325230
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.
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All sexes
Interventional
Not applicable
Bordeaux, France
Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting about 30 to 40 minutes, MRI exam includes successive sequences providing complementary information but none relatively to brain perfusion. Perfusion MRI without contrast media injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as a prognostic factor. The purpose of the study is therefore to perform ASL sequence within usual care brain MRI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ASL sequence added to the usual care brain MRI
Time frame: 3 months of life (Month 3)
judged as favorable, or as adverse in case of death or cerebral palsy
Time frame: Month 6, Month 12
judged as favorable or as adverse
Time frame: Baseline
Prognostic performances of ASL in comparison with routinely used MRI parameters
Time frame: Baseline
according to visual analysis of artifacts and number of negative voxels
Time frame: Baseline
Intra Class correlation coefficient
University Hospital, Bordeaux
Other
Acronym: BBASL
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