Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- early neurological outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients born after the 36th week of gestational age, with signs of encephalopathy found between the 10th minute of life and 6h, presenting with one or more of the following signs of intrapartum hypoxia with a potential of hydrogeb (pH) ≤ 7 or an excess of bases (BE) ≥ 12 mmol/l in the first hour of life, measured on cord or arterial blood or an abnormal course of delivery (eg: fetal heart rate abnormalities, cord prolapse, uterine tear, haemorrhage/ trauma/ convulsive seizures/ maternal cardiorespiratory arrest; shoulder dystocia; meconium-dyed amniotic fluid or protracted second stage and the presence of an Apgar at 10 min ≤5 or the need for continuous respiratory support at 10 minutes.
排除标准
- •mutes neurological objectivity;
- •impossibility of recruitment within 6h;
- •major congenital anomalies, brain malformations;
- •neonatal abstinence syndrome;
- •metabolic encephalopathies and severe growth restriction (birth weight ≤1800g);
- •treatment with therapeutic hypothermia;
- •refusal of consent.
结局指标
主要结局
early neurological outcome
时间窗: at the 12th month.
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
次要结局
- Neurodevelopmental outcome(12th month)
- Hospitalization(between birth until 12th month)
- Electroencephalographic and epilepsy outcome(between the 6 hours of life and 12th month.)
- adverse events(between birth until 12th month)
研究者
Romeo Domenico Marco
Assistant professor, Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS