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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with early diagnosis (within 6 hours of life) of mild HIE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical and instrumental neurological assessment | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| early neurological outcome | the percentage of patients with mild asphyxia with evidence of brain damage, defined by MRI | 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 | at the 6th month |
| early neurological outcome | the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities | at 12th month. |
| early neurological outcome | the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination | at the 3th month |
| early neurological outcome | the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination | at the 6th month. |
| early neurological outcome | the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination | at the 12th month. |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalographic and epilepsy outcome | percentage of abnormalities at electroencephalographic checks and presence of critical events | between the 6 hours of life and 12th month. |
| Neurodevelopmental outcome |
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Inclusion Criteria:
Exclusion Criteria:
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patients with early diagnosis (within 6 hours of life) of mild HIE, who are not candidates for treatment with therapeutic hypothermia
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| Name | Affiliation | Role |
|---|---|---|
| Domenico M Romeo, MD,PHD | ChatolicUIT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli -IRRCS | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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|
percentage of abnormalities at Neurodevelopmental evaluation
| 12th month |
| Hospitalization | Duration of Hospitalization | between birth until 12th month |
| adverse events | Death | between birth until 12th month |
| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |