Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370624
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-09
Brief Title:
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEDI-REAVASC
Brief 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None