PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
- Conditions
- Encephalopathy, Hypoxic-Ischemic
- Interventions
- Diagnostic Test: MRI-scan
- Registration Number
- NCT06370624
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.
- Lack of parental consent
- Congenital anomalies that make hypothermia treatment not indicated
- Coagulopathy with active bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Newborns MRI-scan -
- Primary Outcome Measures
Name Time Method quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE) at birth, directly after hypothermia and at 1 year of baby's life Correlation between RCV mapping EEG/MRI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium