Browsing by Author "Allen, Julian"

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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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    Outpatient Respiratory Management of Infants, Children, and Adolescents with Post-Prematurity Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline
    (American Thoracic Society, 2021) Cristea, A. Ioana; Ren, Clement L.; Amin, Reshma; Eldredge, Laurie C.; Levin, Jonathan C.; Majmudar, Parevi P.; May, Anne E.; Rose, Rebecca S.; Tracy, Michael C.; Watters, Karen F.; Allen, Julian; Austin, Eric D.; Cataletto, Mary E.; Collaco, Joseph M.; Fleck, Robert J.; Gelfand, Andrew; Hayes, Don, Jr.; Jones, Marcus H.; Kun, Sheila S.; Mandell, Erica W.; McGrath-Morrow, Sharon A.; Panitch, Howard B.; Popatia, Rizwana; Rhein, Lawrence M.; Teper, Alejandro; Woods, Jason C.; Iyer, Narayan; Baker, Christopher D.; American Thoracic Society Assembly on Pediatrics; Pediatrics, School of Medicine
    Background: Premature birth affects millions of neonates each year, placing them at risk for respiratory disease due to prematurity. Bronchopulmonary dysplasia is the most common chronic lung disease of infancy, but recent data suggest that even premature infants who do not meet the strict definition of bronchopulmonary dysplasia can develop adverse pulmonary outcomes later in life. This post-prematurity respiratory disease (PPRD) manifests as chronic respiratory symptoms, including cough, recurrent wheezing, exercise limitation, and reduced pulmonary function. This document provides an evidence-based clinical practice guideline on the outpatient management of infants, children, and adolescents with PPRD. Methods: A multidisciplinary panel of experts posed questions regarding the outpatient management of PPRD. We conducted a systematic review of the relevant literature. The Grading of Recommendations, Assessment, Development, and Evaluation approach was used to rate the quality of evidence and the strength of the clinical recommendations. Results: The panel members considered the strength of each recommendation and evaluated the benefits and risks of applying the intervention. In formulating the recommendations, the panel considered patient and caregiver values, the cost of care, and feasibility. Recommendations were developed for or against three common medical therapies and four diagnostic evaluations in the context of the outpatient management of PPRD. Conclusions: The panel developed recommendations for the outpatient management of patients with PPRD on the basis of limited evidence and expert opinion. Important areas for future research were identified.
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    Sleep and pulmonary outcomes for clinical trials of airway plexiform neurofibromas in NF1
    (AAN, 2016-08) Plotkin, Scott R.; Davis, Stephanie D.; Robertson, Kent A.; Akshintala, Srivandana; Allen, Julian; Fisher, Michael J.; Blakely, Jaishri O.; Widemann, Brigitte C.; Ferner, Rosalie E.; Marcus, Carole L.; Department of Pediatrics, School of Medicine
    Objective: Plexiform neurofibromas (PNs) are complex, benign nerve sheath tumors that occur in approximately 25%–50% of individuals with neurofibromatosis type 1 (NF1). PNs that cause airway compromise or pulmonary dysfunction are uncommon but clinically important. Because improvement in sleep quality or airway function represents direct clinical benefit, measures of sleep and pulmonary function may be more meaningful than tumor size as endpoints in therapeutic clinical trials targeting airway PN. Methods: The Response Evaluation in Neurofibromatosis and Schwannomatosis functional outcomes group reviewed currently available endpoints for sleep and pulmonary outcomes and developed consensus recommendations for response evaluation in NF clinical trials. Results: For patients with airway PNs, polysomnography, impulse oscillometry, and spirometry should be performed to identify abnormal function that will be targeted by the agent under clinical investigation. The functional group endorsed the use of the apnea hypopnea index (AHI) as the primary sleep endpoint, and pulmonary resistance at 10 Hz (R10) or forced expiratory volume in 1 or 0.75 seconds (FEV1 or FEV0.75) as primary pulmonary endpoints. The group defined minimum changes in AHI, R10, and FEV1 or FEV0.75 for response criteria. Secondary sleep outcomes include desaturation and hypercapnia during sleep and arousal index. Secondary pulmonary outcomes include pulmonary resistance and reactance measurements at 5, 10, and 20 Hz; forced vital capacity; peak expiratory flow; and forced expiratory flows. Conclusions: These recommended sleep and pulmonary evaluations are intended to provide researchers with a standardized set of clinically meaningful endpoints for response evaluation in trials of NF1-related airway PNs.