In May 2005, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Collaborative Pediatric Critical Care Research Network (CPCCRN) to support multi-institutional randomized controlled trials (RCTs) and observational studies in critically ill children, and the network was competitively renewed in 2009. The CPCCRN currently consists of seven core Clinical Centers, and the Data Coordinating Center (DCC). Since it was established nine years ago, the CPCCRN and its investigators have considered 61 research concepts, created a network registry, implemented 23 studies (including the NHLBI-funded Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) Trials), published 39 peer-reviewed publications, and produced seven public use datasets that are freely available to enable research by additional investigators. Going forward, in addition to the network registry and the THAPCA Trials, CPCCRN has five on-going studies that are anticipated to continue through at least early 2016. These include observational studies of the complications of extracorporeal membrane oxygenation (ECMO) and hemodynamic analyses of cardiopulmonary resuscitation in the intensive care unit, a pharmacometric evaluation of antibiotics during ECMO, and two R01-funded sepsis studies. The University of Utah has been the DCC since network inception, and proposes to continue in this role during the next five years. The DCC faculty bring recognized clinical, biostatistical and informatics expertise to the CPCCRN. This proposal has three specific aims.
Specific Aim 1. Provide clinical and biostatistical leadership and expertise, assistance in study and protocol design, study implementation and management, tracking and delivery methods for study drugs and biological specimens, study training, data collection and management, site monitoring, study reporting, interim and final study analyses, publication of study results, and production of public use research datasets.
Specific Aim 2. Provide logistical support for CPCCRN (including financial management of protocol funds), using advanced communication and informatics tools for development and tracking of critical documents, including study protocols, FAQ documents, Manuals of Operation, training materials, IRB and other regulatory documents, study publications, DSMB reports, and provision of accounting information to NICHD.
Specific Aim 3. Improve efficiency of studies by continuing the voluntary CPCCRN central IRB and refining methods for direct data collection from CPCCRN electronic health records.

Public Health Relevance

The Collaborative Pediatric Critical Care Research Network (CPCCRN) carries out clinical trials and studies to improve the science of pediatric intensive care, and to reduce the mortality and improve the long term outcome for infants and children who suffer from critical illness or injury.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD049934-14
Application #
9395915
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Maholmes, Valerie
Project Start
2005-05-01
Project End
2019-11-30
Budget Start
2017-12-01
Budget End
2018-11-30
Support Year
14
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Utah
Department
Pediatrics
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
Zane, Nicole R; Reedy, Michael D; Gastonguay, Marc R et al. (2017) A Population Pharmacokinetic Analysis to Study the Effect of Therapeutic Hypothermia on Vancomycin Disposition in Children Resuscitated From Cardiac Arrest. Pediatr Crit Care Med 18:e290-e297
Moler, Frank W; Silverstein, Faye S; Holubkov, Richard et al. (2017) Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children. N Engl J Med 376:318-329
Cashen, Katherine; Reeder, Ron; Dalton, Heidi J et al. (2017) Functional Status of Neonatal and Pediatric Patients After Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med 18:561-570
Slomine, Beth S; Nadkarni, Vinay M; Christensen, James R et al. (2017) Pediatric cardiac arrest due to drowning and other respiratory etiologies: Neurobehavioral outcomes in initially comatose children. Resuscitation 115:178-184
Newth, Christopher J L; Sward, Katherine A; Khemani, Robinder G et al. (2017) Variability in Usual Care Mechanical Ventilation for Pediatric Acute Respiratory Distress Syndrome: Time for a Decision Support Protocol? Pediatr Crit Care Med 18:e521-e529
Carcillo, Joseph A; Sward, Katherine; Halstead, E Scott et al. (2017) A Systemic Inflammation Mortality Risk Assessment Contingency Table for Severe Sepsis. Pediatr Crit Care Med 18:143-150
Carcillo, Joseph A; Halstead, E Scott; Hall, Mark W et al. (2017) Three Hypothetical Inflammation Pathobiology Phenotypes and Pediatric Sepsis-Induced Multiple Organ Failure Outcome. Pediatr Crit Care Med 18:513-523
Berger, John T; Holubkov, Richard; Reeder, Ron et al. (2017) Morbidity and mortality prediction in pediatric heart surgery: Physiological profiles and surgical complexity. J Thorac Cardiovasc Surg 154:620-628.e6
Moler, Frank W; Hutchison, Jamie S; Nadkarni, Vinay M et al. (2016) Targeted Temperature Management After Pediatric Cardiac Arrest Due To Drowning: Outcomes and Complications. Pediatr Crit Care Med 17:712-20
Keele, Linda; Meert, Kathleen L; Berg, Robert A et al. (2016) Limiting and Withdrawing Life Support in the PICU: For Whom Are These Options Discussed? Pediatr Crit Care Med 17:110-20

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