UG1HD112063

Duke University Maternal-Fetal Medicine Units (MFMU) Network Clinical Center - Abstract

The Duke University Maternal-Fetal Medicine Units (MFMU) Network Clinical Center is a new center that will participate in the full scope of the network. It will enroll a diverse population of patients at Duke University as well as a satellite site at Wake Forest University (WFU).

Duke University has a long history of participation in the MFMU Network, starting as a clinical center and most recently as a satellite center. The Duke Perinatal Research Center (DPRC) also has extensive experience in enrolling patients for randomized trials and cohort studies with NIAID and CDC networks.

The Duke Clinical Center will bring special strength in developing new research protocols, particularly in the areas of infectious diseases in pregnancy and health disparities in preterm birth. The center's catchment area includes an enriched representation of Black and Latinx individuals from multiple Duke locations, as well as WFU. The team also has a strong track record in clinical trials collaborations, recruitment, retention, and follow-up, which will contribute to the network's goals of enhancing rigor and reproducibility, data sharing, and inclusion of diverse patient groups and workforce.

The center has large-scale outpatient facilities and an established infrastructure for enrolling patients at both high-risk clinics and in collaboration with generalist obstetrics partners in low-risk clinics. Supported by Clinical and Translational Science Awards (CTSAs) at both Duke and WFU, the Duke Clinical Center will promote an environment of equity and inclusion, fostering a respectful climate for all investigators, patients, and participants.

The team has a strong history of collaboration with specialists in pediatrics, pharmacology, and lactation and will leverage those collaborations to bring forward innovative, high-quality science to the MFMU Network.

The proposed specific aims for the Duke Clinical Center are as follows:

AIM 1: Oversee and manage operations of the Duke Clinical Center - Provide the infrastructure, oversight, expertise, and resources to conduct Duke Clinical Center studies, including contributions from the WFU satellite site (and any future MFMU Network-designated sites). This includes administrative, scientific, fiscal, and data management; communication, collaboration, and coordination processes within and between sites.

AIM 2: Maximize recruitment and retention of study participants, as well as investigators and staff, from diverse populations - Use innovative strategies, such as community-based partnerships, bilingual research staff, and conduct of community-engaged research and qualitative methods for enrolling subjects in network studies.

AIM 3: Design and implement high-impact research protocols in collaboration with the Data Coordinating Center and other network sites - Contribute innovative research specifically in the areas of infectious diseases, perinatal pharmacology, disparities in preterm birth, and perinatal epidemiology. Ensure rigorous collection of reproducible, high-quality data and leverage institutional resources to maintain robust collaboration between the investigators and clinical research teams.

Duke University

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Durham, North Carolina 277054640 United States

Single Zip Code

NICHD Maternal-Fetal Medicine Units (MFMU) Network: Clinical Centers (UG1 Clinical Trial Optional) (RFA-HD-23-016)

Amendment Since initial award the total obligations have increased 47% from $700,498 to $1,029,291.