Browsing by Author "Panitch, Howard B."

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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.
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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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    Tidal Breathing Measurements at Discharge and Clinical Outcomes in Extremely Low Gestational Age Neonates
    (ATA, 2018-03) Ren, Clement L.; Feng, Rui; Davis, Stephanie D.; Eichenwald, Eric; Jobe, Alan; Moore, Paul E.; Panitch, Howard B.; Sharp, Jack K.; Kisling, Jeff; Clem, Charles; Kemp, James S.; Pediatrics, School of Medicine
    Rationale: The relationship between respiratory function at hospital discharge and the severity of later respiratory disease in extremely low gestational age neonates is not well defined. Objectives: To test the hypothesis that tidal breathing measurements near the time of hospital discharge differ between extremely premature infants with BPD or respiratory disease in the first year of life compared to those without these conditions. Methods: Study subjects were part of the Prematurity and Respiratory Outcomes Program (PROP) study, a longitudinal cohort study of infants born <29 gestational weeks followed from birth to 1 year of age. Respiratory inductance plethysmography was used for tidal breathing measurements before and after inhaled albuterol 1 week prior to anticipated hospital discharge. Infants were breathing spontaneously and were receiving ≤1 liter per minute (lpm) nasal cannula flow at 21-100% FiO2. A survey of respiratory morbidity was administered to caregivers at 3, 6, 9, and 12 months corrected age to assess for respiratory disease. We compared tidal breathing measurements in infants with and without bronchopulmonary dysplasia (BPD, oxygen requirement at 36 wk) and with and without respiratory disease in the first year of life. Measurements were also performed in a comparison cohort of term infants. Results: 765 infants survived to 36 weeks post-menstrual age, with research-quality tidal breathing data in 452 out of 564 tested (80.1%). Among these 452 infants, the rate of post-discharge respiratory disease was 65.7%. Compared to a group of 18 term infants, PROP infants had abnormal tidal breathing patterns. However, there were no significant differences in tidal breathing measurements in PROP infants who had BPD or who had respiratory disease in the first year of life compared to those without these diagnoses. Bronchodilator response was not significantly associated with respiratory disease in the first year of life. Conclusions: Extremely premature infants receiving <1 lpm nasal cannula support at 21-100% FiO2 have tidal breathing measurements that differ from term infants, but these measurements do not differentiate those preterm infants who have BPD or will have respiratory disease in the first year of life from those who do not.