NCT05767476

Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 10 Minutes – 6 Hours
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: * Identify patients at risk of neuromotor, cognitive and epileptic sequelae * Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: * Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment * Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. * Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. * Brain magnetic resonance imaging between 7 and 14 days. * Electroencephalogram (EEG) within 7 days. After discharge study population will perform: * EEG between 3 and 6 months. * Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. * General Movement Assessment at 3 months. * Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. * Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. * Motor performance assessment using Movement ABC between 42 and 48 months.

Conditions

• Encephalopathy, Hypoxic Ischemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical and instrumental neurological assessment	Participants will be involved in serial assessment: * Neonatal Cranial Ultrasonography * Brain magnetic resonance imaging * Neurological assessment * Neurodevelopmental and cognitive assessment * Electroencephalogram (EEG) * Motor performance assessment

Timeline

• Start date: 2021-04-28
• Primary completion: 2025-08-31
• Completion: 2027-12-31
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

2 sites across 1 country: Italy