Child and Maternal Health

1. Child and Maternal Health

2. Objectives of CMH Program • The CMH program raises awareness of: • CMH investigators within the CCTSI of ongoing CMH research; • mechanisms for assistance to participate and succeed; • pilot grant opportunities; • potential collaborations with on-going research programs and CMH Working Group initiatives. • The CMH Research Program emphasizes the maternal-infant dyad, but all aspects of child health (pediatric) and pregnancy-related research are included, allowing expansion into life course research

3. Governance Director:William W. Hay, Jr. MD (Pediatrics/Neonatology/Perinatal Biology and Medicine/ Perinatal T32 and CHRCD K12) Co-Directors: Obstetrics research program: Vacant Labor & Delivery research activities: Virginia Winn MDPhD (vacant as of June 2014) Neonatology: John Kinsella MD Research Advocate: Vacant Research Nurse Manager, Perinatal CTRC: Vacant—search underway Research Coordinator, Pregnancy Clinic: Chanel Mansfield (temporary)

4. Metrics: Major Accomplishments • Development of the Pregnancy Research Program. • Adaptation of the neonatal subject prioritization schema to pregnancy studies with expansion of the Triage Committee. • Development of the Perinatal Research Facilitation Committee. • Development of a new research program named “Baby Blanket” that allows/promotes (HIPPA general consent) increased recruitment of pregnant women into CCTSI Perinatal CTRC supported research projects and established the Perinatal Database and Biobank. • Growth in number of research projects from our perinatal database. • Efforts to microtize cord blood sample assays and develop a general approach to biosampling (including Consent issues), both available to all investigators. • Clinical Research Space in the new UCH and CHCO NICUs (though insufficient).

5. Major Accomplishments • Website development • New COMIRB panel for pediatrics and maternal-fetal-neonatal research • Chief Research Officer named at CHCO (Fred Suchy MD) • Research Subject Advocate (Terri O’Lonergan, PhD) – expansion of support and assistance for investigators— now vacant, though covered in part by Regulatory and Compliance--Clinical Research Support Center)

6. CMH Research Advocate— A special person for special populations with unique needs. • The Child and Maternal Health Program (CMH) wants to assure that all research we support is of the highest scientific and ethical quality. The Research Advocate (RA) serves two functions. • The CMH RA works with investigators and advises about study design and conduct to assure that the research is of high scientific quality and that the research adequately protects all research participants. Researchers should visit Research Advocacy: For Investigators to find out how the RA can help you and your research. • The CMH RA’s most important function is to be a contact person for all research subjects who have questions or concerns and to design and implement programs to improve participant understanding of research. Research participants, or individuals who are thinking about being in a research study, should click on Research Advocacy: For Participants to find out how the RA can you as a participant, contact information, and access to many resources and useful materials. 

7. Pilot Projects • Funds for the CMH Pilot Awards are generously provided by Children’s Hospital Colorado Research Institute. • $180,000/yr up from $100,000 over the past 3 years. • For 2013, we awarded 9 (of 31 applications) pilot grants. • For 2014, CHCO RI anticipates support for 5 (of 25 applications).

8. 2013 CMH Pilot Projects

9. Perinatal CTRC Activities • Neonatal intensive care unit (NICU) and Labor & Delivery experienced nurses provide expert clinical research support during protocol development, implementation, and data collection • Provide specialized NICU nursing care (UCH, CHCO, St. Joe’s) • Study recruitment • PeaPod(weekends!), Bailey evaluations, NICU nursing care, medication administration • Study implementation with follow-up in the neonatal population 1-2 times/week up to discharge • Data collection & data entry • Screen Labor & Delivery for pre-consented patients from clinic • collect and process cord bloods and placentas • Approach families at extremely vulnerable times—very skilled at this difficult task!

10. Perinatal CTRC Activities • Use of non-nurse Professional Research Assistants (PRAs) to assist with protocol implementation • Increased responsibility of PRAs within their scope of practice • Liaisons to PIs (actually functioning as Co-Is or Research Coordinators—much more than originally planned) • set up protocols • write guidelines & orders • assist with COMIRB renewals/approvals • Troubleshoot nearly all problems • provide education to clinical staff • monitor patients enrolled in long term studies

11. 2013 Neonatal-Perinatal CTRC Activity • Increased FTE’s from 5.7 to 6.5 by changing CTRC model • RNs maintain clinical acumen by staffing in the NICU • Increase PRA FTEs to offset non RN tasks • Restructured role & responsibilities of PRAs as delegated by RNs • PRAs functioning as liaisons for observational protocols • Collaboration with Adult CTRC to provide off hour PRA coverage for Perinatal protocols • Developed RedCap database to manage protocols’ census and Perinatal activity

12. Perinatal CTRC Activity Manages 26 protocols: 6 NICU, 16 L&D, & 4 Newborn Nursery • 11 studies had a combined L&D and NICU/Nursery component • Collect cord blood from 10% of all deliveries with a collection rate of 77% • New subject enrollment rate is 44% of eligible patients • Cord blood and placental collections are among the most difficult of L&D protocols, involving 10% of admitted patients with a collection rate of 77% • Overall, the Perinatal CTRC had contact with 43% of all patients on L&D

13. Perinatal CTRC Activity • 2013 Activity • 1811 “visits”; a 15% decrease from 2012 • 1077 contact hours; a 42% decrease from 2012 • Decreased activity is a result of change in enrollment criteria, protocol completion, protocol overlap (MFMRU competition), and personnel changes • Perinatal activity is not always captured as a visit; majority of work is facilitation, coordination, and education of study protocols • Maintained coverage at 3 hospitals with 24/7 availability, which is unpredictable.

14. CTSA Consortium, Activities and Contributions • Dr. Hay is former voting member of the National CTSA Consortium’s Child Health Oversight Committee (CC-CHOC), a member of the CC-CHOC Operations Committee, and inaugural chair and organizer of the Life Span Working Group (now the Life Course Working Group). In addition, Dr. Hay established and continues to promote the Alliance Society Status of the CC-CHOC with the Pediatric Academic Societies Program Committee. • Dr. Sokol, CCTSI PI and Director, is an ex-officio member of CC-CHOC and its Operating Committee and of the Rare Diseases Working Group within CC-CHOC.

15. Response to Critique from 2013 EAC Review Nothing asked.

16. Plans for Next Year • Fill vacancies: administrative/leadership roles: Ob, L&D, Perinatal CTRC Research Manager, Research Advocate. • The Perinatal CTRC needsoffice and lab space. • Expand/StabilizePerinatal CTRC Research Nursing Support; include more PRAs and other sites; shift burdensome night/weekend call to others. • Expand the CMH Pilot Program—encourage applications.

17. Plans for Next Year • “Encourage” Ob to make pregnant women and their offspring fairly available to all (how to reduce conflict with the MFMU?). • Continue efforts to maintain the Perinatal Research Triage and Facilitation Committees—fundamental !!

18. PRIMARY GOAL OF BABY BLANKET To establish a research database that is linked to clinical data, ultrasound data, laboratory data, and biobank samples of women (and offspring) who initiate their prenatal care at the University of Colorado Hospital (UCH) and plan to deliver their babies at UCH.

19. HIPPA Consent • Administration • of the • Informed Consent

20. Perinatal Database Perinatal Database October 2005 Official Start of Data Collection January 2013 ~Approximately 25,000 records currently in the database~ Maternal Risk Factors Events During Labor & Delivery Complications of Pregnancy Early Neonatal Events

21. LIFE SPAN MODEL WEEKS KEY

22. SNAPSHOT OF THERESEARCH PROTOCOLS GRID Tracking study overlap at the clinic…

23. Department of Pediatrics (Neurology) Department of ObGyn Natinal Jewish Health NIH Projects Supported by Baby Blanket Colorado School of Public health School of Medicine Lynn Barbour MD, MSPH and Teri Hernandez PhD, RN impact of maternal diet on offspring obesity Anne Lynch MD, MSPH Complement Study; Virginia Winn MD, PhD Placental Origins of Preeclampsia (POPE) Study Pia Hauk, MD Antenatal Dietary Supplementation is a Risk Factor for Infant AtopyThrough Epigenetics “Allergy Study” JENNIFER ARMSTRONG-WELLS, MD MPH NEONATAL NEUROLOGICAL OUTCOMES IN MOMS WHO HAVE PROM PPROM OR PREECLAMPSIA DANA DABELEA, MD PHD DEVELOPMENTAL PROGRAMMING (Maternal Obesity and Diabetes--impact on offspring obesity)

24. For now— Anne Lynch will maintain a committee to review applications (all sources) for use of stored perinatal data and biosamples. Approximately 25,000 records in the database ~20,000 longitudinal plasma samples and ~4,000 longitudinal DNA samples, all paired with data. Charges to investigators for this service. We will advertise this service through the CMH-CCTSI website.

25. Plans for Next Year • Re-develop the essential attributes of the Baby Blanket Program: Recruitment for all; Perinatal Data Base; Biobank. Need to be CCTSI and campus resources.

26. Questions for EAC • Competition, Triage and Facilitation: How should we deal with the Ob Department NICHD MFMRU and its restriction of all eligible pregnant women (and fetuses and neonates depending on protocol) to their protocols, which severely limits (shuts down?) research with these subjects for the entire campus (e.g., Ob, Neonatology, Pediatrics, Nursing, Dentistry, Pharmacy, Public Health, School of Medicine, etc.)? • Should there be a budgetfor services other than the Perinatal CTRC, such as a Research Advocate and thePerinatal Research Subject Recruitment Program and Perinatal Database (formerly the Baby Blanket Program)? • Is there now sufficient national CTSA pediatric/child-maternal health activity to warrant further developing and formalizing ours? • How would you recommend getting more Pilot Grant applications?