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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00299-30 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial Spin Labeling sequence | Experimental | ASL sequence added to the usual care brain MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial Spin Labeling sequence | Device | ASL sequence added to the usual care brain MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | judged as favorable, or as adverse in case of death or cerebral palsy | 3 months of life (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | judged as favorable or as adverse | Month 6, Month 12 |
| Prognostic performances of ASL | Prognostic performances of ASL in comparison with routinely used MRI parameters |
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Inclusion Criteria:
neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
presenting with perinatal asphyxia defined as combination of:
an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities);
and at least one of the following criteria:
patient treated or not with therapeutic hypothermia for 72 hours.
affiliated patient or beneficiary of a social security scheme.
informed and signed parental consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline |
| Quality of ASL sequences | according to visual analysis of artifacts and number of negative voxels | Baseline |
| Inter-observer agreement of the interpretation of the perfusion data | Intra Class correlation coefficient | Baseline |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |