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

Background Neonatal 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. Objectives To explore the incidence and two-year outcomes of neonatal stroke across an entire population in the UK and the Republic of Ireland. Population Any infant presenting with neonatal stroke in the first 90 days of life. Design Active national surveillance study using a purpose-built integrated case notification-data collection online platform. Methods Over 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. Conclusion The 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.