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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01435187.
authors.affiliation: Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. gloria_pryhuber@urmc.rochester.edu.
authors.forename: Gloria S
authors.initials: GS
authors.lastname: Pryhuber
authors.affiliation: Monroe Carrell Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. nathalie.maitre@vanderbilt.edu.
authors.forename: Nathalie L
authors.initials: NL
authors.lastname: Maitre
authors.affiliation: Department of Pediatrics, University of California, San Francisco School of Medicine, San Francisco, CA, USA. BallardR@peds.ucsf.edu.
authors.forename: Roberta A
authors.initials: RA
authors.lastname: Ballard
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. cifelli@mail.med.upenn.edu.
authors.forename: Denise
authors.initials: D
authors.lastname: Cifelli
authors.affiliation: Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA. sddavis3@iupui.edu.
authors.forename: Stephanie D
authors.initials: SD
authors.lastname: Davis
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. jellenbe@mail.med.upenn.edu.
authors.forename: Jonas H
authors.initials: JH
authors.lastname: Ellenberg
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. james.greenberg@cchmc.org.
authors.forename: James M
authors.initials: JM
authors.lastname: Greenberg
authors.affiliation: Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA. Kemp_J@kids.wustl.edu.
authors.forename: James
authors.initials: J
authors.lastname: Kemp
authors.affiliation: Department of Pediatrics and Pediatric Molecular and Personalized Medicine Program, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Tom_Mariani@urmc.rochester.edu.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Mariani
authors.affiliation: Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. PANITCH@email.chop.edu.
authors.forename: Howard
authors.initials: H
authors.lastname: Panitch
authors.affiliation: Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. clement_ren@urmc.rochester.edu.
authors.forename: Clement
authors.initials: C
authors.lastname: Ren
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. shawp@mail.med.upenn.edu.
authors.forename: Pamela
authors.initials: P
authors.lastname: Shaw
authors.affiliation: Department of Pediatrics, University of Colorado, Provost's Office, University of Denver, Denver, CO, USA. lynn.taussig@du.edu.
authors.forename: Lynn M
authors.initials: LM
authors.lastname: Taussig
authors.affiliation: Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA. AHamvas@luriechildrens.org.|Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. AHamvas@luriechildrens.org.
authors.forename: Aaron
authors.initials: A
authors.lastname: Hamvas
mesh_terms: D015415:Biomarkers; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000175:diagnosis*; D015931:Intensive Care, Neonatal; D010808:Physical Examination; D011379:Prognosis; D011446:Prospective Studies; D012129:Respiratory Function Tests; D012140:Respiratory Tract Diseases / Q000175:diagnosis*
chemical_list: D015415:Biomarkers