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Active, not recruitingNCT06370624PEDI-REAVASCUpdated May 22, 2025

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

An interventional study of MRI-scan in Encephalopathy, Hypoxic-Ischemic, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Active, not recruiting at 1 site in Belgium. Open to participants aged 1 Hour to 14 Months. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
1 Hour to 14 Months
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
1 Hour to 14 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack of parental consent
  • Congenital anomalies that make hypothermia treatment not indicated
  • Coagulopathy with active bleeding
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Newborns

    Diagnostic Test: MRI-scan

Interventions

  • Diagnostic testMRI-scan

    IRM-scan at rest under neonatologist monitoring.

05

What researchers measure

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

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

06

Study locations

1 site
  • Cliniques Universitaires Saint Luc
    Brussels, 1200, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06370624
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Apr 17, 2024
Start date
Jan 17, 2023
Primary completion
Sep 15, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
May 22, 2025

Study contacts

Valeria Onofrj, MD
principal investigator · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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