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Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy (BBASL)

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ClinicalTrials.gov Identifier: NCT04325230
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Neonatal Hypoxic Ischemic Encephalopathy Device: Arterial Spin Labeling sequence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2022

Arm Intervention/treatment
Experimental: Arterial Spin Labeling sequence
ASL sequence added to the usual care brain MRI
Device: Arterial Spin Labeling sequence
ASL sequence added to the usual care brain MRI




Primary Outcome Measures :
  1. Clinical outcome [ Time Frame: 3 months of life (Month 3) ]
    judged as favorable, or as adverse in case of death or cerebral palsy


Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: Month 6, Month 12 ]
    judged as favorable or as adverse

  2. Prognostic performances of ASL [ Time Frame: Baseline ]
    Prognostic performances of ASL in comparison with routinely used MRI parameters

  3. Quality of ASL sequences [ Time Frame: Baseline ]
    according to visual analysis of artifacts and number of negative voxels

  4. Inter-observer agreement of the interpretation of the perfusion data [ Time Frame: Baseline ]
    Intra Class correlation coefficient



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325230


Contacts
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Contact: Jean-François Chateil, MD, PhD +33556795950 jean-francois.chateil@chu-bordeaux.fr
Contact: Jean Delmas jean.delmas@chu-bordeaux.fr

Locations
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France
CHU Bordeaux
Bordeaux, France
Contact: Jean-François Chateil, MD, PhD       jean-francois.chateil@chu-bordeaux.fr   
Contact: Jean Delmas       jean.delmas@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04325230    
Other Study ID Numbers: CHUBX 2020/01
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Hypoxic-ischemic encephalopathy
Neonate
Perfusion
MRI
Arterial Spin Labeling
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain