Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. Methods: Following central training, standardized SF₆-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3 ± 1.2 years across three centers, and data were analyzed centrally. Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P < 0.05) and with other lung diseases (P < 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.