An observational study in Hypoxic Encephalopathy, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 10 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for treatment with therapeutic hypothermia. The goal of this study is to learn about the early neurological outcome in babies with mild encephalopathy, as recent studies have shown how there is an increased risk of brain damage with a high incidence of resonance magnetic nuclear (RMN) anomalies and possible neurodevelopmental complications including learning or neuropsychological disorders, epilepsy, visual and sensory deficits. The main question aimed to answer is the identification of early possible predictive factors for an unfavorable outcome in order to undertake early rehabilitation programs and for the future planning of trials on early neuroprotection in the investigated population. Babies with early diagnosis (within 6h of life) of mild grade HIE not candidate for hypothermic treatment are subjected to clinical and instrumental assessments during the neonatal period:
After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age:
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 25 observational studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with early diagnosis (within 6 hours of life) of mild HIE, who are not candidates for treatment with therapeutic hypothermia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnostic Test: Clinical and instrumental neurological assessment
During the neonatal period: neurological objective exam according to the modified Sarnat score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation; an AEEG study within 6 hours of life, for 6 hours; cerebral ultrasound within 6 hours of life, in the third and seventh day of life; a brain magnetic resonance imaging study between the seventh and 14th day of life; an EEG evaluation within 7 days. After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age: Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements; evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month; EEG evaluation at the 6th and 12th month.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by MRI
Time frame: between the seventh and 14th day of life
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
Time frame: at the 6th month
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
Time frame: at 12th month.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Time frame: at the 3th month
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Time frame: at the 6th month.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Time frame: at the 12th month.
Electroencephalographic and epilepsy outcome
percentage of abnormalities at electroencephalographic checks and presence of critical events
Time frame: between the 6 hours of life and 12th month.
Neurodevelopmental outcome
percentage of abnormalities at Neurodevelopmental evaluation
Time frame: 12th month
Hospitalization
Duration of Hospitalization
Time frame: between birth until 12th month
adverse events
Death
Time frame: between birth until 12th month
Ran from Feb 2020 to primary completion in Nov 2022, 32 months.
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This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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