Document text
Principal Investigator: MICHAEL W QUASNEY
Organization: UNIVERSITY OF MICHIGAN AT ANN ARBOR
Fiscal Year: 2024
Award: $154,440
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
PROJECT SUMMARY/ABSTRACT – University of Michigan
Pediatric Critical Care Medicine incorporates a multidisciplinary approach to address the medical needs of the
most fragile population of critically ill and injured children. While current mortality rates at most academic, tertiary
care children’s hospitals are below 5%, certain disease processes, notably sepsis and acute respiratory distress
syndrome which are often accompanied with the presence of multiple organ dysfunction syndrome (MODS),
remain associated with significantly higher mortality rates and utilize substantial health care resources. Despite
this, the occurrences of these most challenging diseases do not occur sufficiently often at any one center to
enable an effective, single-site study that will advance both our understanding and management of these
diseases. Mindful of this reality, the Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) demonstrated great insight and vision in funding an infrastructure to create a multi-center
research network, the Collaborative Pediatric Critical Care Research Network (CPCCRN). Our Pediatric Critical
Care program at the University of Michigan, and the division Critical Care Medicine at the Children’s Hospital of
Wisconsin and the Medical College of Wisconsin (MCW) who will participate as our ancillary site, have the
infrastructure to allow us to actively participate in a number of multi-site studies. In addition to possessing this
infrastructure, we also believe both sites have a team of investigators who can make important scientific and
leadership contributions to the field. As a result, we are applying to participate within CPCCRN as a Clinical Site
to assist in executing a large clinical trial investigating the efficacy of GM-CSF in critically ill children with sepsis
entitled, Personalized Immunomodulation in Sepsis-induced MODS. We have the infrastructure and intellectual
capacity to contribute in a meaningful way to the on-going growth and success of this research network that is
committed to improving both the short- and long-term outcomes of critically ill and injured children. The goals of
this proposal are for the Division of Pediatric Critical Care Medicine at the University of Michigan and our partner
ancillary site, the Division of Pediatric Critical Care Medicine at the Medical College of Wisconsin to collaborate
fully with the Executive Committee, the Data Coordinating Center and the other CPCCRN sites. In combination
with our partner ancillary site, our site will provide access to over 100 PICU beds with over 4500 annual
admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced MODS”
trial described in the overall component of this application. Our site proposal has three specific aims to achieve
these goals: 1) to actively collaborate in implementation of the Collaborative Pediatric Critical Care Research
Network clinical trial, 2) to provide opportunities for young investigators at the University of Michigan, as well as
the Medical College of Wisconsin, to participate in CPCCRN meetings, committees, or trial implementation with
the goal of developing these promising and talented individuals into fundable clinician scientists, 3) to implement
the Personalized Immunomodulation in Sepsis-induced MODS trial.
Terms: <0-11 years old><ARDS in children><Address><Admission><Admission activity><Beds><Cardiac><Caring><Child><Child Development><Child Health><Child Youth><Childhood><Childhood Injury><Children (0-21)><Children's Hospital><Clinical Trials><Clinical Trials Network><Collaborations><Contracting Opportunities><Contracts><Critical Care><Critical Illness><Critically Ill><Critically ill children><Data><Data Coordinating Center><Data Coordination Center><Death Rate><Development><Disease><Disease Management><Disorder><Disorder Management><Faculty><Funding><GCP standard><GM-CSF><Generalized Growth><Goals><Good Clinical Practice><Granulocyte-Macrophage Colony-Stimulating Factor><Growth><Healthcare><Histamine-Producing Cell-Stimulating Factor><History><Immunomodulation><Incidence><Individual><Infant and Child Development><Infrastructure><Institution><International><Investigators><K12><K12 Award><K12 Mechanism><K12 Program><Leadership><Lung><Lung Respiratory System><MOF syndrome><Medical><Medicine><Mentored Clinical Scientist Development Program><Mentors><Michigan><Molgramostin><Multi-Institutional Clinical Trial><Multi-center clinical trial><Multi-site clinical trial><Multicenter clinical trial><Multiple Organ Dysfunction Syndrome><Multiple Organ Failure><Multisite clinical trial><NHLBI><NICHD><NIH><National Heart, Lung, and Blood Institute><National Institute of Child Health and Human Development><National Institute of Children's Health and Human Development><National Institutes of Health><Neural Development><Outcome><Paper><Pediatric ARDS><Pediatric Acute Lung Injury><Pediatric Acute Respiratory Distress><Pediatric Acute Respiratory Distress Syndrome><Pediatric Hospitals><Performance><Population><Position><Positioning Attribute><Principal Investigator><Procedures><Process><Program Development><Protocol><Protocols documentation><Publishing><Recording of previous events><Research><Research Personnel><Research Resources><Research Training><Researchers><Resources><Sales><Scientist><Sepsis><Sepsis and ARDS><Sight><Site><TC-GM-CSF><Talents><Tissue Growth><Training><Trauma><Tumor-Cell Human GM Colony-Stimulating Factor><United States National Institutes of Health><Universities><Vision><Vulnerable Populations><Wisconsin><Work><acute respiratory distress syndrome caused by sepsis><blood infection><bloodstream infection><clinical research site><clinical site><critical injury><critically ill child><data management and coordinating center><data management center><determine efficacy><devastating injury><developmental><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><evaluate efficacy><examine efficacy><expectation><granulocyte macrophage colony stimulating factor><health care><histories><immune modulation><immune regulation><immunologic reactivity control><immunomodulatory><immunoregulation><immunoregulatory><implementation science><improved><injured child><injured children><injury in children><insight><interdisciplinary approach><interest><kids><medical college><medical schools><meeting><meetings><member><mindfulness><mortality rate><mortality ratio><multidisciplinary approach><multiorgan failure><multiple organ system failure><neurodevelopment><novel><ontogeny><participant enrollment><patient enrollment><pediatric><pediatric injury><programs><pulmonary><school of medicine><sepsis ARDS><sepsis acute respiratory distress syndrome><sepsis and acute respiratory distress syndrome><sepsis associated acute respiratory distress syndrome><sepsis induced ARDS><sepsis induced acute respiratory distress syndrome><sepsis related acute respiratory distress syndrome><severe injury><success><tertiary care><visual function><vulnerable group><vulnerable individual><vulnerable people><youngster>