@article{3bc083e4aa8344569921f27eaa536378,
title = "Prematurity and respiratory outcomes program (PROP): Study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States",
abstract = "Background: With improved survival rates, short- and long-term respiratory complications of premature birth are increasing, adding significantly to financial and health burdens in the United States. In response, in May 2010, the National Institutes of Health (NIH) and the National Heart, Lung, and Blood Institute (NHLBI) funded a 5-year $18.5 million research initiative to ultimately improve strategies for managing the respiratory complications of preterm and low birth weight infants. Using a collaborative, multi-disciplinary structure, the resulting Prematurity and Respiratory Outcomes Program (PROP) seeks to understand factors that correlate with future risk for respiratory morbidity. Methods/Design: The PROP is an observational prospective cohort study performed by a consortium of six clinical centers (incorporating tertiary neonatal intensive care units [NICU] at 13 sites) and a data-coordinating center working in collaboration with the NHLBI. Each clinical center contributes subjects to the study, enrolling infants with gestational ages 23 0/7 to 28 6/7 weeks with an anticipated target of 750 survivors at 36 weeks post-menstrual age. In addition, each center brings specific areas of scientific focus to the Program. The primary study hypothesis is that in survivors of extreme prematurity specific biologic, physiologic and clinical data predicts respiratory morbidity between discharge and 1 year corrected age. Analytic statistical methodology includes model-based and non-model-based analyses, descriptive analyses and generalized linear mixed models. Discussion: PROP incorporates aspects of NICU care to develop objective biomarkers and outcome measures of respiratory morbidity in the <29 week gestation population beyond just the NICU hospitalization, thereby leading to novel understanding of the nature and natural history of neonatal lung disease and of potential mechanistic and therapeutic targets in at-risk subjects.",
keywords = "Bronchopulmonary dysplasia, Chronic lung disease, Infant, Prematurity, Preterm",
author = "{The Prematurity and Respiratory Outcomes Program Investigators} and Pryhuber, {Gloria S.} and Maitre, {Nathalie L.} and Ballard, {Roberta A.} and Denise Cifelli and Davis, {Stephanie D.} and Ellenberg, {Jonas H.} and Greenberg, {James M.} and James Kemp and Mariani, {Thomas J.} and Howard Panitch and Clement Ren and Pamela Shaw and Taussig, {Lynn M.} and Aaron Hamvas",
note = "Funding Information: Additional funding from the National Institute of Child Health and Human Development (NICHD) through the Best Pharmaceuticals for Children Act (BPCA) allowed expansion of the database collection to include comprehensive medication administration data (in hospital and post-discharge) and the creation of a “PROP Scholars” program to fund competitive and innovative PROP-related subprojects for trainees and junior faculty. Funding Information: Supported by National Institutes of Health, NHLBI and NICHD through U01 HL101794 to University of Pennsylvania, B Schmidt; U01 HL101456 to Vanderbilt University, JL Aschner; U01 HL101798 to University of California San Francisco, PL Ballard and RL Keller; U01 HL101813 to University of Rochester and University at Buffalo, GS Pryhuber, R Ryan and T Mariani; U01 HL101465 to Washington University, A Hamvas and T Ferkol; U01 HL101800 to Cincinnati Children{\textquoteright}s Hospital Medical Center, AH Jobe and CA Chougnet; and 5R01HL105702 to Indiana University and Duke University, CM Cotton, SD Davis and JA Voynow. In addition to the Principal Investigators, the authors would like to acknowledge the critical work of all PROP Site Investigators and research staff at each participating study Center as well as the lead coordinator, Julia Hoffmann, RN, at Washington University, and the lead respiratory therapy coordinator, Charles Clem, RRT, at Indiana University. The PROP logo was designed by R Dadiz. The authors would also like to acknowledge Carol J. Blaisdell, MD, Division of Lung Diseases, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA of NHLBI for her guidance and review of the manuscript as well as all the PROP Investigators (see Appendix 1) for their contributions to the design of individual and multicenter components. Publisher Copyright: {\textcopyright} Pryhuber et al.; licensee BioMed Central.",
year = "2015",
month = apr,
day = "10",
doi = "10.1186/s12887-015-0346-3",
language = "English",
volume = "15",
journal = "BMC Pediatrics",
issn = "1471-2431",
number = "1",
}