Sharp Neonatal Research Institute Clinical Center (Sharp NRI-CC) - PROJECT SUMMARY Research in extremely preterm infants has long been constrained by inadequate enrollment and failure to complete trials. In response to RFA-HD-23-002, this application will demonstrate that the Sharp Neonatal Research Institute (NRI) can substantially contribute as a clinical center (Sharp NRI-CC) in the Eunice Kennedy Shriver NICHD Neonatal Research Network (NRN) 2023-2029 cycle. As a community hospital with high patient volumes, clinical trial expertise, and exceptional participant enrollment, three main strengths underscore Sharp’s application into the NRN: 1) Two Sharp hospitals combined deliver over 10,000 babies in San Diego County, with over 1,500 NICU admissions annually; 2) A highly experienced group of clinical trialists and neurodevelopmental specialists have successfully participated in multiple clinical trials, including previous NRN experience during the 2001-2005 cycle; 3) Sharp’s integration of neonatal research into clinical care which allows for recruitment 24/7 through highly trained personnel who attend all high-risk deliveries and complete the antenatal consent process, with consent rates of over 80% for many clinical trials. Specific Aim 1: Enroll diverse high-risk neonates into current and future NRN trials. The Sharp investigative team has designed and simultaneously led several large multicenter randomized controlled trials (RCT). The Sharp NRI serves a unique population of approximately 40% Hispanic and has a high volume of multiple pregnancies. Specific Aim 2: Participate in NRN trial design and help complete trials efficiently. The proposed Sharp NRI-CC PI, Anup Katheria, MD, has a proven track record of efficiency, leadership, and expertise. He designed and led several large multicenter RCTs and routinely conducts multiple trials simultaneously, including Premature Infants Receiving Milking or Delayed Cord Clamping trial (PREMOD2, 20 centers, N=1,200, est. completion 9/2022) and completed enrollment in the Umbilical Cord Milking in Non-Vigorous Infants trial (MINVI, 10 centers, N=1,730). Both trials enrolled nearly 3,000 participants for secondary studies. Despite PREMOD2 being temporarily stopped, these trials continued enrolling during the pandemic; enrollment was completed in 6 and 3 years (with ongoing 2-year follow-up), respectively. His experienced investigative team including two senior investigators who led the NRN SUPPORT trial and its neurodevelopmental follow-up component, coupled with a productive research team with a strong history of conducting multiple neonatal clinical studies, will provide additional expertise to the NRN. Specific Aim 3: Prioritize long-term neurodevelopmental follow-up in all research trials. The Sharp High Risk Infant Follow-Up program provides longitudinal, comprehensive neurodevelopmental assessments for newborns delivered at Sharp and enrolled in clinical trials that helped increase the overall neonatal follow-up rates to above 85% for recent clinical research trials.
