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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Encephalopathy, Hypoxic-Ischemic Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 hour–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MRI-scan

Diagnostic Test

IRM-scan at rest under neonatologist monitoring.

Primary outcomes

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

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

Correlation between RCV mapping EEG/MRI

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Quantitative Assessment of Cerebral Vascular Reactivity by Resting Functional Magnetic Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment: Diagnostic and Prognostic Implications.

Acronym: PEDI-REAVASC

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 17, 2024
Registry last updated: May 22, 2025

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.

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Completed