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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Active, not recruiting

Conditions: Encephalopathy, Hypoxic-Ischemic

Treatments: Diagnostic Test: MRI-scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06370624

2022/03OCT/360

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 hour to 14 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Newborns

Experimental group

Treatment:

Diagnostic Test: MRI-scan