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

N/AActive Not RecruitingNCT06370624

Cliniques universitaires Saint-Luc- Université Catholique de Louvain30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Encephalopathy, Hypoxic-Ischemic

Interventions

Eligibility

Sex: ALLMin age: 1 HourMax age: 14 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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