Condition: Encephalopathy, Hypoxic Ischemic · Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Intelligenc…
This description comes directly from the study's public registry record.
Domenico M Romeo, MD,PHD · 00390630156391 · domenicomarco.romeo@policlinicogemelli.it
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| Domenico Marco Romeo | Rome, Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli -IRRCS | Rome, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05767476