Title: Evaluation of MR imaging to predict neurodevelopmental impairment in preterm infants
Funder: Department of Health (England)

Abstract: • Aims and objectives This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants. The component projects: 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; and 6. develop further novel MR methods to predict neurodevelopmental impairment. • Background Preterm birth is the leading cause of perinatal mortality and morbidity in developed countries, and leads to neurological impairment in a significant proportion of survivors. Targeting follow-on services to children who need them is difficult, particularly with inaccurate early diagnosis of neurodevelopmental impairment. In a research environment MR is more accurate at detecting cerebral abnormalities than standard-of-care cranial ultrasonography and might provide a more accurate neurological prognosis and improve overall care. However more sensitive imaging might also increase parental anxiety and make the care pathway more expensive but less satisfactory. • Research plans The programme uses randomised and non-randomised components to evaluate the intervention ‘referral for specialist MR imaging’ as an addition to routine ultrasonography. Referred infants will undergo both MR and ultrasound imaging at a specialist imaging facility. Familes will then be randomly assigned to receive prognostic information based upon only one of the two investigations. Parental perceptions and coping, healthcare use and total costs will be assessed until 20 months corrected age when neurodevelopmental outcome will be assessed. A survey of current use and capacity will aid any decision to implement MR and provide a baseline to assess change in practice, while an assessment of optimal ultrasound delivery will inform policy if MR is found to be ineffective or cannot be provided. Development and evaluation of novel MR methods will be continued. • Research team The project will be carried out within the North and South West Thames Perinatal Networks in collaboration with Imperial College and the National Perinatal Epidemiology Unit. The Imperial group has expertise in ultrasound and MR imaging for preterm infants, and neurodevelopmental assessment; the National Perinatal Epidemiology Unit which has extensive experience of the assessment of perinatal interventions, parental responses and economic evaluation. • Research environment The two Perinatal Networks provide a representative sample of the population of preterm infants cared for by the NHS. Both networks have a mixture of level 1,2 and 3 intensive care units, and have Research and Development Committees which have approved participation in this programme. The imaging referral centre will be the Neonatal Imaging Facility at Hammersmith Hospital. • Anticipated outputs, outcomes and impact The predicted outcome of this programme is a policy decision on whether MR should be added to the NHS care pathway for infants born at less than 30 weeks gestational age. The policy decision will impact on the efficiency and/or effectiveness of care of preterm infants and their families and on overall healthcare costs to the NHS. • Public involvement There has been user collaboration in this research since the inception of the project through lay participation in the Neonatal Imaging Facility Operational Board, the North West Thames Perinatal Network Users Group and the UKCRN Medicines for Children Research Network Consumer Liaison Group. These groups have supported the importance of the question being addressed and confirmed that the trial design is appropriate for Consumers. • Ethical implications The programme randomises information, and therefore withholds it from some families. This raises ethical questions which have been addressed by Consumers, who agreed this was an important issue, but felt that equipoise existed on the value of imaging and thus the study was ethically desirable in order to provide parents information about the future of their infants which they strongly felt as needed. However, they felt that brain imaging was stressful, and if it did not add useful information they would not want it for their children. • Justification for resources requested. The MR facility is provided by MRC and Imperial College; we require marginal costs: principally salary support and per item imaging. Applicants’ salaries are related to their time commitment.


Research activity codes: 4.3 INFLUENCES AND IMPACT;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: NEUROLOGICAL;REPRODUCTIVE HEALTH AND CHILDBIRTH