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.