Preventing Stroke Triggers in Children With Sickle Cell Anaemia in Mulago Hospital, Kampala (PREST ): a Randomized Control Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of stroke
研究概览
简要总结
Sickle cell anaemia (SCA) is a common hereditary haemoglobin disorder in Africa. World wide it is estimated that about 300,000 newborns are born every year. Of which 75% of them live in Sub-saharan Africa (SSA). In Uganda, about 15,000 babies are born with sickle cell disease per year.
In Uganda, the stroke prevalence was found to be 6.2% in children admitted to the National referral hospital in Kampala. Notable between 21 to 30% of these children presented with co-morbidities such as anaemia, bacteraemia and painfull crisis. Stroke in SCA is mediated by several mechanism such as cellular adhesions, inflammatory markers, hemolysis associated oxidative stress and hemostatic activation. Stroke in SCA is primarily a large vessel stroke and the mechanisim state above lead to a narrowing of the lumen of the cerebral arteries Arterial ischaemic stroke which occurs frequently in children with SCA has been associated with bacterial infections. Recent studies have shown that minor infections such as flu like infections can play a critical role in the trigger of stroke in children.
Our hypothesis is that viral flu infections is a key trigger for the risk of stroke in children with SCA. Our objective is to prevent the occurrence of flu illnesses in children with SCA thereby reducing the risk for stroke in our population of children with SCA.
Methods: A randomized controlled double blinded study Study site: The study will be conducted at the Sickle Cell Clinic (SCC), Mulago Hospital. Inclusion criteria: will be ;age between 2 years and 12 years;All children whose parents will have consented and those above 7years will have to assent. Exclusion criteria: all children with previous strokes; children who have acute illness and are not clinically stable; any child with previous documented adverse event following immunization (AEFI).
Sample Size: Using Open EPI calculator for cohort studies we calculated a total sample size of 136 participant to achieve our objective. Using a 95% confidence interval, power of 80% and an unexposed outcome of 25% (4) using a ratio of 1:1. Each arm will have 68 participants. With anticipated 10% loss to follow up a total sample size of 150 with each arm having 75 participants.
Study utility: Globally, stroke triggers have been recently identified independent of the existing risk factors such as high cerebral velocity speeds on TCDs. Flues like illnesses have been reported to be stroke triggers in children with arterial ischaemic strokes worldwide.This study may influence the role of influenza vaccination in the prevention of stroke triggers in children with sickle cell anaemia. It will also add to the existing modalities which have helped to reduce the incidence of stroke amongst this high risk group of children with
详细描述
Preventing Stroke Triggers in Children with Sickle Cell Anaemia in Mulago Hospital, Kampala (PREST): A Randomized Control Trial
Principal Investigator: Deogratias Munube ( MBChB, MMed) Department of Paediatrics and Child Health
Mentor: Prof . James.K. Tumwine (MBChB, MMed, PhD) Prof . Grace Ndeezi (MBChB, MMed, PhD)
Research hypothesis: Our hypothesis is that viral flu infections is a key trigger for the risk of stroke in children with SCA. Our objective is to prevent the occurrence of flu illnesses in children with SCA thereby reducing the risk for stroke in our population of children with SCA.
Rational for research: Globally, stroke triggers have been recently identified independent of the existing risk factors such as high cerebral velocity speeds on TCDs. Flues like illnesses have been reported to be stroke triggers in children with arterial ischaemic strokes worldwide. This study may influence the role of influenza vaccination in the prevention of stroke triggers in children with sickle cell anaemia. It will also add to the existing modalities which have helped to reduce the incidence of stroke amongst this high risk group of children with
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant and the study team will both be masked to which arm the participant will be assigned. Blinding will be achieved by use of a placebo that has similar characteristics as the influenza vaccine i.e. as the vaccine, the placebo will be formulated and packaged as an injectable placebo. In addition, on enrollment, the participants will be informed by the study team that their assignment to a study arm is completely random and unknown to the study team. The study nurse will pick the study drug from the pharmacist to be used for each participant after the randomization code has been revealed. The randomization code on the study drug will have to be the same as the code in the envelope. Lastly, the envelopes will be kept off site with the statistician who will deliver them every morning before the clinic opens.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age between 2 years and 12 years
- •All children whose parents will have consented and those above 7years will have to assent
排除标准
- •• All children with previous strokes
- •Children who have acute illness and are not clinically stable
- •Any child with previous documented adverse event following immunization (AEFI).
结局指标
主要结局
Incidence of stroke
时间窗: 12 months
• Incidence of stroke: The incidence of stroke is defined as the occurrence of a focal neurological deficit in a child lasting at least 24 hours if it has a vascular basis during the study period. Each child suspected to have stroke will have a brain cranial tomography (CT) scan done to confirm the diagnosis. This diagnosis will then be adjudicated by a team comprising of a pediatrician, neurologist and a radiologist.
次要结局
- VCAM levels(12)
研究者
College of Health Sciences
makchs
Makerere University