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.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZHL1)
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Blaisdell, Carol J
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University of Pennsylvania
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