PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
NCT ID: NCT06370624
Last Updated: 2025-05-22
Study Results
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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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2023-01-17
2025-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Newborns
MRI-scan
IRM-scan at rest under neonatologist monitoring.
Interventions
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MRI-scan
IRM-scan at rest under neonatologist monitoring.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Congenital anomalies that make hypothermia treatment not indicated
* Coagulopathy with active bleeding
1 Hour
14 Months
ALL
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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2022/03OCT/360
Identifier Type: -
Identifier Source: org_study_id
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