Non-invasive meningitis screening in neonates and infants: multicentre international study.

Abstract

Meningitis diagnosis requires a lumbar puncture (LP) to obtain cerebrospinal fluid (CSF) for a laboratory-based analysis. In high-income settings, LPs are part of the systematic approach to screen for meningitis, and most yield negative results. In low- and middle-income settings, LPs are seldom performed, and suspected cases are often treated empirically. The aim of this study was to validate a non-invasive transfontanellar white blood cell (WBC) counter in CSF to screen for meningitis. We conducted a prospective study across three Spanish hospitals, one Mozambican and one Moroccan hospital (2020-2023). We included patients under 24 months with suspected meningitis, an open fontanelle, and a LP performed within 24 h from recruitment. High-resolution-ultrasound (HRUS) images of the CSF were obtained using a customized probe. A deep-learning model was trained to classify CSF patterns based on LPs WBC counts, using a 30cells/mm³ threshold. The algorithm was applied to 3782 images from 76 patients. It correctly classified 17/18 CSFs with <math xmlns="http://www.w3.org/1998/Math/MathML"><mo>≥</mo></math> 30 WBC, and 55/58 controls (sensitivity 94.4%, specificity 94.8%). The only false negative was paired to a traumatic LP with 40 corrected WBC/mm³. This non-invasive device could be an accurate tool for screening meningitis in neonates and young infants, modulating LP indications. Our non-invasive, high-resolution ultrasound device achieved 94% accuracy in detecting elevated leukocyte counts in neonates and infants with suspected meningitis, compared to the gold standard (lumbar punctures and laboratory analysis). This first-in-class screening device introduces the first non-invasive method for neonatal and infant meningitis screening, potentially modulating lumbar puncture indications. This technology could substantially reduce lumbar punctures in low-suspicion cases and provides a viable alternative critically ill patients worldwide or in settings where lumbar punctures are unfeasible, especially in low-income countries).