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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 14 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.
Exclusion Criteria
- •Lack of parental consent
- •Congenital anomalies that make hypothermia treatment not indicated
- •Coagulopathy with active bleeding
Outcomes
Primary Outcomes
quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE)
Time Frame: at birth, directly after hypothermia and at 1 year of baby's life
Correlation between RCV mapping EEG/MRI
Secondary Outcomes
No secondary outcomes reported