Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767476
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2023-03-03
Brief Title:
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Thompsons 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
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 Thompsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None