Prevention of Epilepsy by Reducing Neonatal Encephalopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- Epilepsy
研究概览
简要总结
The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in India.
The care bundle will have four key elements (interventions): (1) birth companion providing constant 1:1 care during labour and early perinatal period; (2) fetal surveillance during active labour by a nurse or midwife using a graphic display Doppler; (3) labour management by an electronic partogram with an 'alert' and 'nag' feature based on the current WHO guidelines; (4) brain oriented early newborn care with resuscitation where indicated.
The care bundle will be evaluated using a prospective interrupted time series design, recruiting 80,000 women delivering in one of the three participating centres in south India, over two years. Accurate baseline data will be collected during the first year and the optimised care bundle will be introduced during the second year. All full term newborn infants admitted to the neonatal unit with perinatal brain injury during both periods, will have detailed assessments including video electroencephalography, and magnetic resonance imaging, and will be followed up until 18 months of age.
Primary outcome is the number of infants with epilepsy (categorised per current ILAE guidelines) at 18 months of age expressed as per 1000 term livebirths. The investigators will use a segmented logistic regression to divide the time series into pre- and post-intervention segments, with the intervention date as the intersection between segments. The difference in the two segments will be quantified using the level (step change) and slope (trend change). The total duration of the study is four years including 24 months of recruitment and 18 months of follow-up.
详细描述
Epilepsy is a condition where individuals are prone to recurrent epileptic seizures; which means a change in the electrical activity of the brain resulting in a change in behaviour or movement. Epilepsy is a symptom of the condition of which there are many different causes, including brain injury occurring around the time of birth.
Worldwide approximately 50-70 million people have epilepsy, and 4.6 million develop epilepsy each year. The incidence of epilepsy in low and middle-income countries (LMICs) (1.3 per 1000 people) is 2 to 3 times higher than that in high-income countries (0.49 per 1000 people). The Prevention Task Force of the International League Against Epilepsy [1] estimated that perinatal brain insults accounted for the largest attributable fraction of paediatric and adult epilepsy in LMICs with median (95% confidence intervals) estimated fractions of 17.4% (14.7 to 18.9) and 11.4% (7.8 to 15.4). The contribution (population attributable risk) of perinatal brain insults towards preventable epilepsy is 3 times higher than that of central nervous system infections with parasites, virus and bacteria (5.3%), and traumatic brain injury (6.6%). The task force concluded that health programmes to improve prenatal and intrapartum care in LMIC may prevent a substantial proportion of epilepsy in LMICs[1].
12 million people were estimated to be living with epilepsy in India in 2015, accounting for 1/6th of the global epilepsy burden [2]. The annual economic burden of epilepsy to the Indian economy was estimated to be £1.3 billion ($1.74 USD) with a cost of £260 ($344 USD) per patient per year in 2001[3], based on the burden of 5 million people with epilepsy in India at that time. Hence the current costs, based on 12 million people with epilepsy in 2015 [2], may be much higher. Approximately 500,000 new epilepsy cases occur in India every year[3], of which 87,000 (17.4%) are likely to be related to a birth related brain injury. The vast majority of these cases will have additional neurodisabilities including cerebral palsy, deafness and blindness. Hence, the social and economic burden of epilepsy related to perinatal brain injury is likely to be much higher than isolated epilepsy.
Hypothesis. Epilepsy from perinatal brain injury can be reduced by the use of a pragmatic, evidenced based and generalisable intrapartum care bundle that involves birth companions, intelligent fetal heart rate monitoring, an e-partogram and brain oriented neonatal resuscitation, in Indian public sector hospitals.
5. Aims and objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Magnetic resonance biomarkers will be quantified masked to the interventional group
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pregnant women delivering at 36 weeks or later
排除标准
- •Premature deliveries
结局指标
主要结局
Epilepsy
时间窗: 18 months of age
Two of more unprovoked seizures at least 24 hours apart
次要结局
- Neonatal encephalopathy(24 hours of birth)
- Thalamic N-aspartate levels(2 weeks of age)
- Neonatal Seizures(1 month of age)
- Brain injury on conventional MR imaging(2 weeks of age)