Encephalopathy, Hypoxic-Ischemic
Conditions
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.
Interventions
DIAGNOSTIC_TESTMRI-scan
IRM-scan at rest under neonatologist monitoring.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) & the MRI-scan performed at the same time.
Eligibility
Sex/Gender
ALL
Age
1 Hours to 14 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed