- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325230
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy (BBASL)
April 27, 2023 updated by: University Hospital, Bordeaux
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arterial Spin Labeling sequence
ASL sequence added to the usual care brain MRI
|
ASL sequence added to the usual care brain MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome
Time Frame: 3 months of life (Month 3)
|
judged as favorable, or as adverse in case of death or cerebral palsy
|
3 months of life (Month 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome
Time Frame: Month 6, Month 12
|
judged as favorable or as adverse
|
Month 6, Month 12
|
Prognostic performances of ASL
Time Frame: Baseline
|
Prognostic performances of ASL in comparison with routinely used MRI parameters
|
Baseline
|
Quality of ASL sequences
Time Frame: Baseline
|
according to visual analysis of artifacts and number of negative voxels
|
Baseline
|
Inter-observer agreement of the interpretation of the perfusion data
Time Frame: Baseline
|
Intra Class correlation coefficient
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2020
Primary Completion (Actual)
January 12, 2023
Study Completion (Actual)
January 12, 2023
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2020/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Hypoxic Ischemic Encephalopathy
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Turku University HospitalNot yet recruitingNeonatal Stroke | Neonatal Hypoxic Ischemic Encephalopathy | Neonatal Encephalopathy, UnspecifiedFinland
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Neonatal Encephalopathy Consortium, JapanNational Cerebral and Cardiovascular Center; Nagoya University; Tokyo Women's... and other collaboratorsUnknownNeonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)Japan
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Assiut UniversityUnknownNeonatal Hypoxic Ischemic Encephalopathy
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Assiut UniversityUnknownNeonatal Hypoxic Ischemic Encephalopathy
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Michael CottenCompletedNeonatal Hypoxic Ischemic EncephalopathyUnited States
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Neonatal Encephalopathy Consortium, JapanNational Cerebral and Cardiovascular Center; Nagoya University; Tokyo Women's... and other collaboratorsCompletedNeonatal Encephalopathy | Hypoxic-ischemic EncephalopathyJapan
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Pharmazz, Inc.RecruitingHypoxic-Ischemic Encephalopathy | Neonatal Encephalopathy | Neonatal AsphyxiaIndia
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