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

NCT ID: NCT06370624

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Encephalopathy, Hypoxic-Ischemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Newborns

Group Type EXPERIMENTAL

MRI-scan

Intervention Type DIAGNOSTIC_TEST

IRM-scan at rest under neonatologist monitoring.

Interventions

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MRI-scan

IRM-scan at rest under neonatologist monitoring.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

14 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valeria Onofrj, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2022/03OCT/360

Identifier Type: -

Identifier Source: org_study_id

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