Back to resultsPrognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy (BBASL)
Primary Purpose
Neonatal Hypoxic Ischemic Encephalopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arterial Spin Labeling sequence
Sponsored by
About this trial
This is an interventional other trial for Neonatal Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic-ischemic encephalopathy, Neonate, Perfusion, MRI, Arterial Spin Labeling
Eligibility Criteria
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:
- 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 Criteria:
- perinatal arterial ischemic stroke.
- congenital neuro-metabolic disorder.
- severe malformative abnormalities.
- MRI contra-indication.
- Poor understanding of the holders of parental authority
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arterial Spin Labeling sequence
Arm Description
ASL sequence added to the usual care brain MRI
Outcomes
Primary Outcome Measures
Clinical outcome
judged as favorable, or as adverse in case of death or cerebral palsy
Secondary Outcome Measures
Clinical outcome
judged as favorable or as adverse
Prognostic performances of ASL
Prognostic performances of ASL in comparison with routinely used MRI parameters
Quality of ASL sequences
according to visual analysis of artifacts and number of negative voxels
Inter-observer agreement of the interpretation of the perfusion data
Intra Class correlation coefficient
Full Information
NCT ID
NCT04325230
First Posted
March 16, 2020
Last Updated
April 27, 2023
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04325230
Brief Title
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
Acronym
BBASL
Official Title
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2020 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoxic Ischemic Encephalopathy
Keywords
Hypoxic-ischemic encephalopathy, Neonate, Perfusion, MRI, Arterial Spin Labeling
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arterial Spin Labeling sequence
Arm Type
Experimental
Arm Description
ASL sequence added to the usual care brain MRI
Intervention Type
Device
Intervention Name(s)
Arterial Spin Labeling sequence
Intervention Description
ASL sequence added to the usual care brain MRI
Primary Outcome Measure Information:
Title
Clinical outcome
Description
judged as favorable, or as adverse in case of death or cerebral palsy
Time Frame
3 months of life (Month 3)
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
judged as favorable or as adverse
Time Frame
Month 6, Month 12
Title
Prognostic performances of ASL
Description
Prognostic performances of ASL in comparison with routinely used MRI parameters
Time Frame
Baseline
Title
Quality of ASL sequences
Description
according to visual analysis of artifacts and number of negative voxels
Time Frame
Baseline
Title
Inter-observer agreement of the interpretation of the perfusion data
Description
Intra Class correlation coefficient
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
8 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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 Criteria:
perinatal arterial ischemic stroke.
congenital neuro-metabolic disorder.
severe malformative abnormalities.
MRI contra-indication.
Poor understanding of the holders of parental authority
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
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