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
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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.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.
Exclusion Criteria:
Diagnostic Test: MRI-scan
IRM-scan at rest under neonatologist monitoring.
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
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Sep 2025, 31 months after the start.
Of 46 non-industry interventional studies with no phase under Hypoxia-Ischemia, Brain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's planned 31 months is close to that.
Counting every sponsor, half of 47 studies reached it within 33 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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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