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

NCT ID: NCT04325230

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-17
• Study Completion Date: 2023-01-12

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.

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.

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arterial Spin Labeling sequence

ASL sequence added to the usual care brain MRI

Group Type: EXPERIMENTAL

Arterial Spin Labeling sequence

Intervention Type: DEVICE

ASL sequence added to the usual care brain MRI

Interventions

Arterial Spin Labeling sequence

ASL sequence added to the usual care brain MRI

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 8 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2020/01

Identifier Type: -

Identifier Source: org_study_id