Status:
COMPLETED
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Neonatal Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
1-8 years
Phase:
NA
Brief Summary
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 newb...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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:
- Apgar score ≤ 5 at 10 minutes of life,
- mask ventilation or intubation at 10 minutes of life,
- metabolic acidosis defined as pH \< 7 or base deficit ≥ 16 mmol/L or lactates ≥ 11 mmol/L within the first 60 minutes of life on cord or other arterial venous or capillary blood sample.
- 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
- perinatal arterial ischemic stroke.
- congenital neuro-metabolic disorder.
- severe malformative abnormalities.
- MRI contra-indication.
- Poor understanding of the holders of parental authority
Key Trial Info
Start Date :
May 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04325230
Start Date
May 17 2020
End Date
January 12 2023
Last Update
April 28 2023
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France