Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors
研究概览
简要总结
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.
详细描述
This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4°C following perinatal asphyxia improves survival without neurodevelopmental disability.
Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming.
The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing.
Eligibility criteria:
Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a combination of clinical and EEG criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The infant will be assessed sequentially by criteria A, B and C listed below:
- •A. Infants =>36 completed weeks gestation admitted to the Neonatal Intensive Care Unit (NICU) with at least one of the following:
- •Apgar score of =<5 at 10 minutes after birth
- •Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
- •Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH <7.00)
- •Base Deficit =>16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth
- •Infants that meet criteria A will be assessed for whether they meet the neurological abnormality entry criteria (B) by trained personnel:
- •B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
- •hypotonia
- •abnormal reflexes including oculomotor or pupillary abnormalities
- •absent or weak suck
- •clinical seizures
- •Infants that meet criteria A & B will be assessed by amplitude-integrated electroencephalogram (aEEG) (read by trained personnel):
- •C. At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
- •normal background with some seizure activity
- •moderately abnormal activity
- •suppressed activity
- •continuous seizure activity
排除标准
- •Infants expected to be > 6 hours of age at the time of randomisation
- •Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis
研究组 & 干预措施
cooled
Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
干预措施: Whole body mild induced hypothermia (Procedure)
non-cooled
Standard intensive care
结局指标
主要结局
Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors
时间窗: 18 months
Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean \[± standard deviation (SD)\] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.
次要结局
- Culture Proven Sepsis(Duration of hospital stay, on average 22 days)
- Major Venous Thrombosis(Duration of hospital stay, on average 22 days)
- Sensorineural Hearing Loss(18 months)
- Intracranial Haemorrhage(Duration of hospital stay, on average 22 days)
- Persistent Hypotension(Duration of hospital stay, on average 22 days)
- Pulmonary Hypertension(Duration of hospital stay, on average 22 days)
- Prolonged Blood Coagulation Time(Duration of hospital stay, on average 22 days)
- Necrotising Enterocolitis(Duration of hospital stay, on average 22 days)
- Cardiac Arrhythmia(Duration of hospital stay, on average 22 days)
- Thrombocytopenia(Duration of hospital stay, on average 22 days)
- Pulmonary Haemorrhage(Duration of hospital stay, on average 22 days)
- Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)(18 months)
- Renal Failure Treated With Dialysis(Duration of hospital stay, on average 22 days)
- Severe Neurodevelopmental Disability(18 months)
- Microcephaly(18 months)
- Pneumonia(Before discharge from hospital)
- Pulmonary Airleak(Duration of hospital stay, on average 22 days)
- Duration of Hospitalisation(Duration of hospital stay, on average 22 days)
- Mortality(18 months)
- Multiple Handicap(18 months)
- Bayley Psychomotor Developmental Index Score (PDI)(18 months)