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Clinical Trials/NCT06370624
NCT06370624Active, not recruitingNot Applicable

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.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country30 target enrollmentStarted: January 17, 2023Last updated:
Conditions

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

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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