New England Research Institutes, Inc. (NERI) is applying to continue its 10-year role as the Data Coordinating Center (DCC) for the Pediatric Heart Network (PHN). The PHN will continue as a cooperative network of up to 8 Clinical Centers, 15 auxiliary sites, a DCC, a Network Chair, and NHLBI Project Scientists. The objectives of the PHN are to 1) provide an infrastructure for multi-center collaborative clinical research, and 2) to evaluate diagnostic, medical, interventional, and surgical therapies for congenital heart defects, inflammatory heart disease, heart muscle disease, and arrhythmias. As the DCC, NERI will continue to provide scientific and logistical support for the next cycle of the Network, with key responsibilities and functions for leadership in study design and statistics, overall study coordination and management of data acquisition;leadership in development activities for bioinformatics infrastructure and tools;electronic information and data systems;logistical and support services;and management and distribution of Network funds. A multiple PI leadership plan is proposed to continue the leadership roles shared by Dr. Sleeper (Clinical and Statistical Science) and Dr. Tennstedt (Network Operations), with clearly delineated roles and responsibilities for leading and directing the DCC, intellectually and operationally. Importantly, the DCC staff will be organized to include a Network Manager who is also the Manager for the NHLBI Bench to Bassinet Program. This will position the DCC to facilitate integration of the PHN as the clinical trials component of the B2B Program.

Public Health Relevance

The mission of the Pediatric Heart Network is to improve the health and quality of life for children, adolescents, and young adults who are born with heart defects or develop heart disease by conducting large clinical studies at many medical centers. The Data Coordinating Center provides important services to guide and support this research.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL068270-12
Application #
8299551
Study Section
Special Emphasis Panel (ZHL1-CSR-S (M4))
Program Officer
Pemberton, Victoria
Project Start
2001-09-06
Project End
2016-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
12
Fiscal Year
2012
Total Cost
$8,334,847
Indirect Cost
$932,827
Name
New England Research Institute
Department
Type
DUNS #
153914080
City
Watertown
State
MA
Country
United States
Zip Code
02472
Selamet Tierney, Elif Seda; Levine, Jami C; Sleeper, Lynn A et al. (2018) Influence of Aortic Stiffness on Aortic-Root Growth Rate and Outcome in Patients With the Marfan Syndrome. Am J Cardiol 121:1094-1101
Mussatto, Kathleen A; Hollenbeck-Pringle, Danielle; Trachtenberg, Felicia et al. (2018) Utilisation of early intervention services in young children with hypoplastic left heart syndrome. Cardiol Young 28:126-133
Newburger, Jane W; Sleeper, Lynn A; Gaynor, J William et al. (2018) Transplant-Free Survival and Interventions at 6 Years in the SVR Trial. Circulation 137:2246-2253
Goldberg, David J; Zak, Victor; Goldstein, Bryan H et al. (2018) Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial. Am Heart J 201:1-8
Hoskoppal, Arvind; Menon, Shaji; Trachtenberg, Felicia et al. (2018) Predictors of Rapid Aortic Root Dilation and Referral for Aortic Surgery in Marfan Syndrome. Pediatr Cardiol 39:1453-1461
Mahle, William T; Hu, Chenwei; Trachtenberg, Felicia et al. (2018) Heart failure after the Norwood procedure: An analysis of the Single Ventricle Reconstruction Trial. J Heart Lung Transplant 37:879-885
Saarel, Elizabeth V; Granger, Suzanne; Kaltman, Jonathan R et al. (2018) Electrocardiograms in Healthy North American Children in the Digital Age. Circ Arrhythm Electrophysiol 11:e005808
Minich, L LuAnn; Pemberton, Victoria L; Shekerdemian, Lara S et al. (2018) The Pediatric Heart Network Scholar Award programme: a unique mentored award embedded within a multicentre network. Cardiol Young 28:854-861
Ramroop, Ronand; Manase, George; Lu, Danny et al. (2017) Adrenergic receptor genotypes influence postoperative outcomes in infants in the Single-Ventricle Reconstruction Trial. J Thorac Cardiovasc Surg 154:1703-1710.e3
Rollins, Caitlin K; Asaro, Lisa A; Akhondi-Asl, Alireza et al. (2017) White Matter Volume Predicts Language Development in Congenital Heart Disease. J Pediatr 181:42-48.e2

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