Design and implementation of a multicenter protocol to obtain impulse oscillometry data in preterm children

Abstract

Importance: Objective measures of lung function are critical for assessingrespiratory outcomes of prematurity. Among extremely low gestational ageneonates (ELGANs) (<29 weeks gestational age), high rates of neurode-velopmental impairment may interfere with lung function testing. Impulseoscillometry (IOS) is a noninvasive test of respiratory system mechanics notrequiring forced expiration. Objective: To describe a multicenter study design for respiratory follow-uptesting in a cohort with a high rate of extreme prematurity. Methods: School-age children enrolled in two prior trials of ELGANs andterm controls were assessed by IOS at five centers. Groups consisted ofchildren with prematurity with a high incidence of bronchopulmonary dys-plasia, children with prematurity with no or minimal lung disease, andhealthy term children. A rigorous centralized review process reviewed IOSstudies for technical acceptability. Approach to design and implementa-tion, rates of feasibility and success, and characteristics of participants aredescribed. Results: A total of 243 children were recruited, of whom 239 (98%)attempted oscillometry. There were high rates of technical acceptabil-ity across all three cohorts (85%-90% of attempted tests), and acrossall five centers (80%-94% of attempted tests). Respiratory and neuro-motor clinical factors associated with testing failure included a highernumber of days on ventilation during neonatal intensive care, a historyof intraventricular hemorrhage grade 3 or 4, and gross motor functionalimpairment. Interpretation: We report high rates of feasibility and success of oscillom-etry in a large multicenter ELGAN population, in whom neurological anddevelopmental comorbidities likely play a confounding role.