PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

NCT06370624 | Active Not Recruiting

• 1 other identifier: 2022/03OCT/360
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores. The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.

Conditions

Encephalopathy, Hypoxic-Ischemic

Outcome Measures

Primary Outcomes (1)

• quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE)

  Correlation between RCV mapping EEG/MRI

  at birth, directly after hypothermia and at 1 year of baby's life

Study Arms (1)

Newborns

EXPERIMENTAL

Diagnostic Test: MRI-scan

Interventions

MRI-scan DIAGNOSTIC_TEST

IRM-scan at rest under neonatologist monitoring.

Newborns

Eligibility Criteria

• Age: 1 Hour - 14 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.

You may not qualify if:

• Lack of parental consent
• Congenital anomalies that make hypothermia treatment not indicated
• Coagulopathy with active bleeding

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Magnetic Resonance Imaging

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Valeria Onofrj, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: January 17, 2023
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)