Browsing by Subject "Pulmonary function tests"

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    Design and implementation of a multicenter protocol to obtain impulse oscillometry data in preterm children
    (Wiley, 2024-09-25) Tsukahara, Katharine; Ren, Clement L.; Allen, Julian; Bann, Carla; McDonough, Joseph; Ziolkowski, Kristina; Clem, Charles C.; DeMauro, Sara B.; Pediatrics, School of Medicine
    Importance: Objective measures of lung function are critical for assessing respiratory outcomes of prematurity. Among extremely low gestational age neonates (ELGANs) (< 29 weeks gestational age), high rates of neurodevelopmental impairment may interfere with lung function testing. Impulse oscillometry (IOS) is a noninvasive test of respiratory system mechanics not requiring forced expiration. Objective: To describe a multicenter study design for respiratory follow-up testing in a cohort with a high rate of extreme prematurity. Methods: School-age children enrolled in two prior trials of ELGANs and term controls were assessed by IOS at five centers. Groups consisted of children with prematurity with a high incidence of bronchopulmonary dysplasia, children with prematurity with no or minimal lung disease, and healthy term children. A rigorous centralized review process reviewed IOS studies for technical acceptability. Approach to design and implementation, rates of feasibility and success, and characteristics of participants are described. Results: A total of 243 children were recruited, of whom 239 (98%) attempted oscillometry. There were high rates of technical acceptability across all three cohorts (85%-90% of attempted tests), and across all five centers (80%-94% of attempted tests). Respiratory and neuromotor clinical factors associated with testing failure included a higher number of days on ventilation during neonatal intensive care, a history of intraventricular hemorrhage grade 3 or 4, and gross motor functional impairment. Interpretation: We report high rates of feasibility and success of oscillometry in a large multicenter ELGAN population, in whom neurological and developmental comorbidities likely play a confounding role.
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    Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis
    (Elsevier, 2016-05) Davis, Stephanie D.; Ratjen, Felix; Brumback, Lyndia C.; Johnson, Robin C.; Filbrun, Amy G.; Kerby, Gwendolyn S.; Panitch, Howard B.; Donaldson, Scott H.; Rosenfeld, Margaret; Department of Pediatrics, IU School of Medicine
    BACKGROUND: The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint. METHODS: Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials. RESULTS: Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0). CONCLUSIONS: iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials.