This is an application from the Division of Neonatology and the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania (Penn) School of Medicine to serve as the Data Coordinating Center (DCC) for the Prematurity and Respiratory Outcomes Program (PROP).The long-term goal of the PROP collaboration is to improve respiratory outcomes during the first year of life after preterm birth. The PROP DCC will provide scientific expertise and logistical support to the PROP collaboration for the following 5 specific aims: 1.To provide expertise in neonatology, pediatric pulmonology, biostatistics, epidemiology and clinical research methodology and to share in the scientific leadership of the PROP collaboration in developing a multicenter prospective research approach to the study of biomarkers and other diagnostic and risk models;2.T0 develop a World Wide Web-based comprehensive data management system for up to three collaborative protocols and coordination of all multi-center PROP activities;3. To provide comprehensive administrative support for the PROP Research Network, promoting effective communications, coordinating meetings, working groups, document development and management, and distribution of study proceedings among the network entities;4. To provide site management services including oversight of Clinical Research Centers (CRCs) compliance with regulatory requirements and human subject protection practices, as well as monitoring performance in implementation of the protocol, providing support for and monitoring of clinical start-up procedures, answering queries, and resolving issues as they arise;5. To develop data analysis and monitoring plans, provide statistical collaboration for the PROP manuscripts, and to provide input and support for preparing and submitting joint presentations and publications. One of the most important scientific contributions of the PROP DCC to the PROP collaboration will be to ensure that the multicenter project(s) is rigorously designed, executed and analyzed according to the highest methodological standards. (End of Abstract)

Public Health Relevance

More than 12% of all babies in the US are born too small and too soon. Many of these preterm infants either die or survive with long-lasting respiratory problems.
The aim of this research is to better understand the breathing difficulties after preterm birth, and to help find means of reducing the heavy burden of respiratory illness in this vulnerable population of children.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL101794-01
Application #
7867704
Study Section
Special Emphasis Panel (ZHL1-CSR-D (F1))
Program Officer
Gail, Dorothy
Project Start
2010-05-01
Project End
2015-04-30
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
1
Fiscal Year
2010
Total Cost
$449,962
Indirect Cost
Name
University of Pennsylvania
Department
Pediatrics
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Levy, Philip T; Patel, Meghna D; Choudhry, Swati et al. (2018) Evidence of Echocardiographic Markers of Pulmonary Vascular Disease in Asymptomatic Infants Born Preterm at One Year of Age. J Pediatr 197:48-56.e2
Blaisdell, Carol J; Troendle, James; Zajicek, Anne et al. (2018) Acute Responses to Diuretic Therapy in Extremely Low Gestational Age Newborns: Results from the Prematurity and Respiratory Outcomes Program Cohort Study. J Pediatr 197:42-47.e1
Sucre, Jennifer M S; Jetter, Christopher S; Loomans, Holli et al. (2018) Successful Establishment of Primary Type II Alveolar Epithelium with 3D Organotypic Coculture. Am J Respir Cell Mol Biol 59:158-166
Hamvas, Aaron; Feng, Rui; Bi, Yingtao et al. (2018) Exome sequencing identifies gene variants and networks associated with extreme respiratory outcomes following preterm birth. BMC Genet 19:94
Choudhry, Swati; Salter, Amber; Cunningham, Tyler W et al. (2017) Normative Left Ventricular M-Mode Echocardiographic Values in Preterm Infants up to 2 kg. J Am Soc Echocardiogr 30:781-789.e4
Levy, Philip T; El-Khuffash, Afif; Patel, Meghna D et al. (2017) Maturational Patterns of Systolic Ventricular Deformation Mechanics by Two-Dimensional Speckle-Tracking Echocardiography in Preterm Infants over the First Year of Age. J Am Soc Echocardiogr 30:685-698.e1
Brennan, Colleen; Ulm, Lara; Julian, Samuel et al. (2017) Thoracoabdominal Asynchrony Is Not Associated with Oxyhemoglobin Saturation in Recovering Premature Infants. Neonatology 111:297-302
Keller, Roberta L; Feng, Rui; DeMauro, Sara B et al. (2017) Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study. J Pediatr 187:89-97.e3
Levy, Philip T; Patel, Meghna D; Groh, Georgeann et al. (2016) Pulmonary Artery Acceleration Time Provides a Reliable Estimate of Invasive Pulmonary Hemodynamics in Children. J Am Soc Echocardiogr 29:1056-1065
Benjamin, John T; van der Meer, Riet; Im, Amanda M et al. (2016) Epithelial-Derived Inflammation Disrupts Elastin Assembly and Alters Saccular Stage Lung Development. Am J Pathol 186:1786-1800

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