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Pediatric CTRC
Clinical and Research Services
The first priority of the Pediatric Clinical Translational Research Center (Pediatric CTRC) is to provide research nursing and exemplary patient care to children admitted under research protocols. The inpatient unit is also active in providing care for non-research patients, including care for patients with cystic fibrosis. Clinical research facilities also include perinatal and pediatric "scatterbed nurses," an ambulatory research unit and a perinatal unit.
In addition to 18 research nurses, the Pediatric CTRC facilities are supported by a research bionutrition unit,
biostatisticians, core laboratory,
bioinformatics core,
Research Subject Advocate Program and
Scientific Advisory Committee.
Recently, the CTRC announced a new Molecular Genetics Core, utilizing the facilities and personnel at the The Children's Hospital Molecular Diagnostic Laboratory and the DNA Diagnostic Laboratory at UCDHSC. Services to be offered to investigators will include performance of polymerase chain reaction testing for detection of infectious agents and isolation of gene segments, gene sequencing and detection of mutations and polymorphisms.
Pediatric CTRC Inpatient Unit
Located on 4NW at The Children's Hospital (TCH), this ten-bed inpatient unit opened in May of 1990 at TCH (previously located at University of Colorado Hospital for 28 years). The Pediatric CTRC staff provides unit coverage 24 hours a day, seven days a week, primarily for patient-oriented research, with patients ranging from healthy volunteers to acutely ill patients. Nursing expertise in research and patient care is provided. The unit primarily encompasses pediatric patients, but also accommodates adult patients. The Pediatric CTRC is unique in both its approach to patient care and its technical expertise. The nurses continually develop new skills to meet the requirements of the protocols. The Pediatric CTRC strongly advocates TCH's policy of "Family Centered Care."
Pediatric CTRC Outpatient Unit
The nucleus of the outpatient Pediatric CTRC is located in the Medical/Surgical Specialties Clinic, on the third floor of the Health Center at The Children's Hospital (TCH). Research outpatient visits can be coordinated through special research examining rooms available in the clinic, or with ongoing clinical care visits for patients involved with specialty care providers/investigators. Depending upon the needs of approved protocols, research support can also be provided at offsite locations of TCH. Staffing consists of a Clinical Nurse Specialist/ Pediatric Nurse Practitioner and a Program Assistant. Hours of operation are Monday through Friday, 8 a.m. to 5 p.m.
Perinatal Unit
The Perinatal CTRC "Scatterbed" Nurses are based in the Neonatal Intensive Care Unit at University of Colorado Hospital (UCH). Five full-time, highly trained research nurses assist with CTRC-approved research studies at the bedside of the patient, principally at UCH and The Children's Hospital. Though most studies are conducted during the day, Monday through Friday, the nurses do cover 24 hours a day, seven days a week. The perinatal nurses are fully versed in the methodology of clinical research and perform duties essential to maintaining the highest clinical research standards. They identify potential research patients, collect research samples and data, provide care for infants enrolled in complicated studies and provide teaching and support for parents of study patients.
Pediatric CTRC "Scatterbed" Nurses
Two "Scatterbed" Research Nurses at The Children's Hospital assist with CTRC-approved research studies at the bedside of patients (non-neonatal) who are who are too ill to be admitted to the Pediatric CTRC Inpatient Unit. Most studies are conducted Monday through Friday during the day. The nurses identify potential research subjects, collect data and samples and provide care for patients enrolled in CTRC-approved research protocols.
Bionutrition Unit
The Bionutrition Unit of the CTRC is a team with extensive research experience. The Bionutrition Unit supports inpatient and outpatient studies at The Children's Hospital, providing advice and services to investigators regarding study design, methodology and outcome measures related to nutrition and relevant to the primary topic of the research protocol. Available services include assistance in development of nutrition components in protocols; dietary intake analysis and weighed food/dietary intakes; diet history; research diet design and implementation; resting energy expenditure measures using indirect calorimetry; physical activity assessment, growth and body composition measures, including skinfolds, BIA, DEXA and circumferences; advice on biomarkers appropriate for outcomes of interest; and bone mineral density testing by DEXA.
Biostatistical Services
As part of the protocol submission process, PhD-level biostatisticians provide evaluation and feedback to investigators prior to protocol review by the CTRC Scientific Advisory Committee. Services include guidance on study design; sample size and power calculations; guidance on data abstraction and storage; test method selection and data analysis; manuscript writing support; DSMB reports; and hypothesis generation.
Core Lab
The Pediatric CTRC Core Laboratory is staffed by senior medical technologists and is located at TCH. The Core Laboratory is available to develop and provide a broad spectrum of high-complexity chemical and immunological non-routine assays for CTRC-approved protocols. These assays are intended to complement assays undertaken in the investigator's own laboratory and are not available in the hospital clinical laboratory. The Core Lab is accredited through CAP (Commission on Laboratory Accreditation of the College of American Pathologists) and CLIA (Clinical Laboratory Improvement Act). Assays available include inflammatory mediators, cytokines and chemokines, bone metabolism, vitamins and antioxidants. New assays are being developed continually based upon the needs of investigators. For a full list of assays, see the main Pediatric CTRC website.
Informatics/BioInformatics
The BioInformatics Core supports investigators and CTRC staff with all data management and security needs in cooperation with hospital Information Systems groups, including review of all protocols, making technical suggestions regarding data collection/analysis and regulatory (HIPAA) compliance; evaluation, specification, purchase and installation of new desktop/network technology; hardware/network/software problem-solving; database design and maintenance, data queries, assistance in analysis and reporting; CTRC website management and information sharing; secure data transfer between individuals and organizations; training for new/current technology via the CTRC Learning Resource Center; and lead developments in pediatric bioinformatics for advanced genomic research.
Research Subject Advocacy Program
The CTRC Research Subject Advocate (RSA) provides evaluation and assistance in formulating and implementing data and safety monitoring provisions for research involving human subjects (Data Safety Monitoring Plans, Data Safety Monitoring Boards); and consultation about research subject issues, consent, staff education and presentations. The RSA is available to investigators, staff and subjects with questions or concerns. Mentors, interns and students may also perform independent study in bioethics (through UCD, UCD, UCB, DU).
Scientific Advisory Committee
The Scientific Advisory Committee (SAC) meets monthly to review and comment upon protocols submitted by investigators applying for CTRC support. There is also a course in the Clinical Sciences PhD Program (CLSC 7300) "General Clinical Research Center (GCRC) SAC Review Process" at the Graduate School of UCD, in which students participate in SAC review.
GCRC Advisory Committee
The GCRC Advisory Committee (GAC) meets quarterly and has oversight over administrative, budgetary and utilization issues. The GAC is composed of ten senior investigators who have knowledge of the functioning of the CTRC and other NIH and local programs, the CTRC Program Director, Associate Program Directors and CTRC management staff.
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