Non-invasive detection and monitoring of childhood meningitis (“UNITED Meningitis - Ultrasound Non-Invasive Technology for Early Diagnosis of Meningitis”)

Meningitis can be a life-threatening disease if not promptly diagnosed and treated. Among infants and neonates with a permeable fontanelle, clinical presentation is usually unspecific, justifying the need for an invasive procedure such as lumbar puncture (LP) in order to rule in or out meningitis. This investigation aims to validate a non-invasive, ultrasound-based transfontanelllar device to screen for meningitis by counting WBC beneath the anterior fontanelle. A customized ultrasonic probe working at 20mHz will be used to detect white blood cells, and deep-learning models will be trained for classification. The proof-of-concept study will include 16 participants, and sensitivity and specificity of the device will be calculated. The study will be performed in three Spanish Hospitals, and will include children under 12 months old, a permeable fontanelle, suspected meningitis and a LP performed within 24h before recruitment. The expected time to reach the pre-defined sample size is 18 months.