Neonatal Research in Intensive Care Nursery
The Intensive Care Nursery (ICN) is a 58-bed unit that serves a diverse range of neonatal conditions and provides research opportunities at a Level IV NICU. The ICN facilitates study screening and recruitment with a focus on optimizing access to research for infants and families while limiting the burden on families. The process for research protocol review involves collaboration with ICN staff and leadership for successful study implementation.
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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 1y 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
