NCT05785481

Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 10 Minutes – 6 Hours
• Healthy volunteers: Not accepted

Summary

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: * 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 Amplitude Electroencephalogram (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 Electroencephalogram (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.

Conditions

• Hypoxic Encephalopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-27
• Primary completion: 2022-11-07
• Completion: 2024-12-31
• First posted: 2023-03-27
• Last updated: 2023-03-27

Locations

1 site across 1 country: Italy