Protocol for the British Paediatric Surveillance Study of Neonatal Stroke in the United Kingdom and the Republic of Ireland in babies in the first 90 days of life
Authors: Kwok T’ng Chang , Dineen Robert A , Whitehouse William , Lynn Richard M , McSweeney Niamh , Sharkey Don 
Published: April 2022

AbstractBackgroundNeonatal stroke is a devastating condition that causes brain injury in babies and often leads to lifelong neurological impairment. Recent, prospective whole population studies of neonatal stroke are lacking. Neonatal strokes are different from those seen in older children and adults. A better understanding of the aetiology, current management and outcomes of neonatal stroke could reduce the burden of this rare condition. Most healthcare professionals see only a few cases of neonatal stroke in their careers, so population-based prospective studies are needed.ObjectivesTo explore the incidence and two-year outcomes of neonatal stroke across an entire population in the UK and the Republic of Ireland.PopulationAny infant presenting with neonatal stroke in the first 90 days of life.DesignActive national surveillance study using a purpose-built integrated case notification-data collection online platform.MethodsOver a 13-month period, British and Irish clinicians will notify any cases of neonatal stroke electronically via the online platform monthly. Clinicians will complete a primary questionnaire via the platform detailing clinical information, demographic details and investigations, including neuroimaging for detailed analysis and classification. An outcome questionnaire will be sent at two years of age via the platform. Appropriate ethical and regulatory approvals have been received from England, Wales, Scotland, Northern Ireland and the Republic of Ireland.ConclusionThe neonatal stroke study represents the first multinational population surveillance study delivered via a purpose-built integrated case notification-data collection online platform and data safe haven, overcoming the challenges of setting up the study.SynopsisStudy questionThe neonatal stroke active surveillance study aims to explore the incidence and two-year outcome of neonatal stroke in the UK and Ireland.What is already known?Neonatal stroke is a rare but often devastating condition with lifelong consequences including cerebral palsy, epilepsy and cognitive delay. There are no contemporary, prospective multinational population studies on the presentation and outcomes of neonatal stroke. Whilst often the aetiology is multifactorial further information on underlying aetiology may help to identify potential future preventative treatments leading to improved outcomes.What does this study add?International collaboration is required to understand the epidemiology, management and outcomes of rare diseases or conditions. This is the first multinational surveillance study delivered via a purpose-built integrated case notification-data collection online platform and data safe haven, presenting practical and ethical challenges. The study will describe the burden of neonatal stroke while providing parents/carers and healthcare professionals with up-to-date information about the condition including the two-year outcomes.