NCT05767476招募中不适用
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Neurodevelopmental outcome
研究概览
简要总结
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, Thompson's 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.
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
- •All infants with gestational age ≥ 35 weeks and with a body weight ≥ 1800 g were considered eligible, if they satisfied the following criteria:
- •Intrapartum hypoxia defined as follows: potential of hydrogen (pH)≤ 7.0 or B.E. ≥ 16 millimole liters (mmo/L) in the 1st hour of life, obtained from cord or arterial blood, or (ii) pathological intra-partum course (e.g., abnormal foetal heart rate, cord prolapse, uterine rupture, maternal haemorrhage/trauma/epileptic seizures/cardiorespiratory arrest, shoulder dystocia, fluid meconium-stained amniotic), or Apgar score ≤5 or continuous respiratory support at 10 minutes.
- •Signs of moderate or severe encephalopathy according to the Sarna (t) score and Sarna (t) staging, performed at 30-60 minutes of life: stage 2 (lethargic, poor spontaneous activity, distal flexion posture, hypotonia, weak primitive reflexes, myotic pupils, bradycardia or periodic breathing) or stage 3 (stupor/coma, decerebrate posture, spontaneous activity absent, flaccidity, primitive reflexes absent, non-reactive pupils or apnoea).
- •Amplitude integrated electroencephalogram( aEEG ) by Cerebral Functional Monitoring (CFM) or electroencephalogram (EEG) for at least 30 minutes, which shows either moderate or severe electroencephalographic anomalies, or the presence of convulsions.
- •All enrolled infants underwent therapeutic hypothermia according to the international guideline for 72 hours.
排除标准
- •Infants with:
- •gestational age <35 weeks,
- •severe foetal growth restriction (body weight <1800 g),
- •inability to start therapeutic hypothermia within 6 hours of birth,
- •other known causes of encephalopathy (chromosomopathies, brain malformations, metabolic encephalopathies, major congenital anomalies, neonatal withdrawal syndrome), - incoercible bleeding,
- •refusal of consent by the parent/guardian/legal representative
结局指标
主要结局
Neurodevelopmental outcome
时间窗: 24th months
the score in Griffiths Mental Development Scales (GMDS)
次要结局
- Neurodevelopmental outcome(between 36th and 42th months)
- Motor coordination outcome(between 42th and 48th months.)
研究者
Romeo Domenico Marco
MD, PHD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (2)
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