NCT06370624

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

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 1 Hour – 14 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Encephalopathy, Hypoxic-Ischemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI-scan	IRM-scan at rest under neonatologist monitoring.

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-09-15
• Completion: 2025-10-01
• First posted: 2024-04-17
• Last updated: 2025-05-22

Locations

1 site across 1 country: Belgium