Data Management Core: pivotal to the success of Baby Blanket-related projects is the data management core that provides consultation to researchers on the availability and use of the perinatal database (and other databases), study design, IRB submissions, biostatistics, data analysis, abstract and manuscript preparation. This core has also become a hub for mentoring and education for faculty, fellows, residents, MSPH and medical students.
Clinical Core: active recruitment into the clinical component of Baby Blanket started in 2011 at the University of Colorado Hospital (UCH) prenatal clinics. Every women attending the UCH clinic for their first prenatal visit is invited to be part of the program. At this visit the woman is consented to be part of the program and both clinical data and biological samples are collected. The woman is followed in pregnancy and outcomes are collected on Labor and Delivery. The Baby Blanket participants make up a unique cohort of women whose data and biological samples accessible to research investigators interested in perinatal research.
Biorepository Core: at the Baby Blanket recruitment visit, biological samples are collected. The samples are aliquoted and stored in the Baby Blanket Biorepository. This unique repository allows Investigators to analyze biomarkers even in a cross sectional study.
Research Facilitation Core: the Research Facilitation Core is organized around: 1) a Perinatal Research Facilitation Committee, composed of senior faculty and administrators from across campus that meet biannually to address and advise on complex issues related to perinatal research, 2) a Triage Committee that meets monthly to review perinatal research protocols and monitor the number of projects in the prenatal clinic, on Labor and Delivery and in the Neonatal Intensive Care Units, and 3) a Recruitment Database that houses the records of women who agree to be contacted for inclusion in perinatal research. At the University of Colorado Hospital’s prenatal clinics, Children’s Hospital Colorado’s teen pregnancy clinic, and the Metro Community Providers Network’s (MCPN) prenatal clinics, women have the option of being contacted for inclusion in perinatal research studies. Women who "opt in" are entered into a Recruitment Database and are prescreened for inclusion in various protocols. Investigators utilizing this database then have the ability to contact women who are interested in being research subjects.
Clinical Trials Core: Baby Blanket provides support to the Maternal Fetal Medicine Units Network (MFMU) which functions under the National Institute of Child Health and Human Development (NICHD). The MFMU is designed to conduct perinatal studies to improve maternal and fetal outcomes. The University of Colorado is one of the fourteen university-based clinical centers conducting clinical research. The Clinical Recruitment and Clinical Trials Cores are involved with patient recruitment for two MFMU studies: Congenital Cytomegalovirus Infection: Randomized Placebo-Controlled Trial (CMV) and an Observational Study of Hepatitis C Virus in Pregnancy (HCV).
This core is also leading efforts at the Denver site for the NICHD sponsored, Effects of Aspirin in Gestation and Reproduction (EAGeR) Trial. The EAGeR Trial closed recruitment in July of 2011 with 1,229 women enrolled nationally. Dr. Anne Lynch is the PI for EAGeR Denver and remains a vital member of the EAGeR Investigators Committee, EAGeR Adverse Events Committee as well as the EAGeR Publications Committee. The Denver team continues to support the Program Director at the NIH, Enrique Schisterman, PhD in finalizing the dataset. The EAGeR Trial was presented at the Society for Maternal-Fetal Medicine (SMFM) as a late breaking publication February 11-16, 2013 in San Francisco.
With a strong research infrastructure in place, the hope is to draw more clinical trials to our site in the future.