Intensive Care Nursery ICN 58 bed unitall beds

Intensive Care Nursery (ICN) • 58 -bed unit—all beds licensed for intensive care • Two paths to admission ─ Inborn via UCSF Labor + Delivery: fetal referrals (Fetal Treatment Center)/ maternal transfers/UCSF OB + high-risk practices (~2/3 of admissions) ─ Outborn: transfer after birth (~1/3 of admissions) • Broad geographic catchment area—To Oregon + Nevada borders, Bakersfield, Southern CA and out-of-state • Primary Neonatology service for 90 -95% of patients (remainder Pediatric Medicine) ─ 3 Neonatology teams with different attendings ─ Co-management with primary surgical teams, Cardiology, Neurology

ICN: research opportunities • “Level IV” (quarternary) NICU: all neonatal medical + surgical services, including cardiopulmonary bypass (ECMO + intraoperative) ─ Broad support services for all aspects of neonatal/infant care • Diverse conditions/pathophysiology ─ Prematurity + sequelae, congenital anomalies (surgical/non-surgical conditions +/sequelae +/- prematurity), neurological conditions, infection/ sepsis and/or respiratory distress/failure ─ Acute + chronic illness ─ Short + prolonged (to 1 y chronologic age) hospitalizations ─ Multi-system disease common • Diverse/varying family backgrounds ─ Family composition ─ Language, literacy + numeracy ─ Resources for inpatient + outpatient care

Study screening + recruitment in the ICN Goals • Optimize access to research for infants/families • Optimize study enrollment for clinical investigators • Limit burden on families from study approaches ─ Multiple study approaches ─ Study approaches at times of substantial distress ─ Enhance clear communication among study teams and with research administration regarding interest in participating in research/specific types of research (observational vs. interventional)

ICN process for research protocol review • Letter of support required at time of IRB submission • Investigator(s)/research staff meeting with ICN research leadership ─ 1 -2 paragraph synopsis of study aims and procedures ─ Identify processes to optimize assistance of ICN staff with facilitation/ completion of study aims/procedures and those procedures that will require investigative team effort ─ Discuss consent process/personnel • Synopsis edited + submitted for publication in monthly ICN newsletter