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Completed

NCT Number: NCT04325230

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial Spin Labeling sequence

Device

ASL sequence added to the usual care brain MRI

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: BBASL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.