PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

Encephalopathy, Hypoxic-Ischemic Clinical Trial

— PEDI-REAVASC  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06370624
• Other study ID #: 2022/03OCT/360
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 1, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 14 Months

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Encephalopathy, Hypoxic-Ischemic
• Hypothermia
• Hypoxia
• Hypoxia, Brain
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Diagnostic Test:
• MRI-scan
IRM-scan at rest under neonatologist monitoring.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE)	Correlation between RCV mapping EEG/MRI	at birth, directly after hypothermia and at 1 year of baby's life