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

NCT04325230 | Completed

• 1 other identifier: CHUBX 2020/01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic-ischemic encephalopathy; Neonate; Perfusion; MRI; Arterial Spin Labeling

Outcome Measures

Primary Outcomes (1)

• Clinical outcome

  judged as favorable, or as adverse in case of death or cerebral palsy

  3 months of life (Month 3)

Secondary Outcomes (4)

• Clinical outcome

  Month 6, Month 12

• Prognostic performances of ASL

  Baseline

• Quality of ASL sequences

  Baseline

• Inter-observer agreement of the interpretation of the perfusion data

  Baseline

Study Arms (1)

Arterial Spin Labeling sequence

EXPERIMENTAL

ASL sequence added to the usual care brain MRI

Device: Arterial Spin Labeling sequence

Interventions

Arterial Spin Labeling sequence DEVICE

ASL sequence added to the usual care brain MRI

Arterial Spin Labeling sequence

Eligibility Criteria

• Age: 1 Day - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• perinatal arterial ischemic stroke.
• congenital neuro-metabolic disorder.
• severe malformative abnormalities.
• MRI contra-indication.
• Poor understanding of the holders of parental authority

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 27, 2020
• Study Start: May 17, 2020
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)