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

Neonatal Hypoxic Ischemic Encephalopathy Clinical Trial

— BBASL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325230
• Other study ID #: CHUBX 2020/01
• Status: Completed
• Phase: N/A
• Start date: May 17, 2020
• Est. completion date: January 12, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 8 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia
• Neonatal Hypoxic Ischemic Encephalopathy

Intervention

Device:
• Arterial Spin Labeling sequence
ASL sequence added to the usual care brain MRI

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	judged as favorable, or as adverse in case of death or cerebral palsy	3 months of life (Month 3)
Secondary	Clinical outcome	judged as favorable or as adverse	Month 6, Month 12
Secondary	Prognostic performances of ASL	Prognostic performances of ASL in comparison with routinely used MRI parameters	Baseline
Secondary	Quality of ASL sequences	according to visual analysis of artifacts and number of negative voxels	Baseline
Secondary	Inter-observer agreement of the interpretation of the perfusion data	Intra Class correlation coefficient	Baseline