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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Treatments

Device: Arterial Spin Labeling sequence

Study type

Interventional

Funder types

Other

Identifiers

NCT04325230
CHUBX 2020/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

1 to 8 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Arterial Spin Labeling sequence
Experimental group
Description:
ASL sequence added to the usual care brain MRI
Treatment:
Device: Arterial Spin Labeling sequence

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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