Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 625
- 试验地点
- 13
- 主要终点
- This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants.
研究概览
简要总结
Preterm infants face an uncertain future because premature birth often leads to problems with brain development and can cause cerebral palsy.
A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and professionals by predicting long term problems more accurately, allowing better targeting of care to children with problems and reassuring the parents of normal babies.
This programme will provide the evidence-base for the National Health System (NHS) policy on the use of magnetic resonance imaging of the brain for preterm infants.
详细描述
The trial will determine very accurately how well MRI predicts long-term problems, and it will assess whether it makes parents more or less anxious about their babies, and whether they seek more or less help in the first couple of years after birth,and see if the total cost to the NHS is increased by using MRI. It will also check up if there is a better way to do ultrasound examinations, and do a survey to see how much MRI is used in the United Kingdon (UK) and whether hospitals think they could provide it.
The core of the project is a study of preterm babies who will be referred to a specialist centre to have both ultrasound and MRI scans. Half the parents will be told the results of the MRI and half the parents the ultrasound. The programme will then ask them to fill in questionnaires or be interviewed about their stress levels and the amount of support they seek for their children until they are two years old, when the babies will be examined to see if MRI predicted their outcome accurately.
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
- — 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Delivery at less than 33 completed weeks of gestation, estimated from early fetal ultrasonographic measurements as recommended in the National Institute of Clinical Excellence Guidelines: Antenatal Care for the Healthy Woman
排除标准
- •Prior MR imaging
- •Major Congenital Malformations
- •Presence of Metallic Implants
结局指标
主要结局
This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants.
时间窗: 5 years
1. Determine with high precision the sensitivity and specificity of cerebral MR imaging for predicting neurodevelopmental impairment in the context of the NHS. 2. Use a randomised design to compare the effect of MR and ultrasound imaging on total healthcare usage and costs, and assess its effect on unplanned and planned care. 3. Compare the influence of MR- and ultrasound-based information on parental perceptions, stress and coping. 4. Compare routine local bedside with specialist centralised ultrasound imaging. 5. Survey current MR use and capacity in the NHS. 6. Develop further novel MR methods to predict neurodevelopmental impairment.
次要结局
未报告次要终点