15 - Building a HIE Registry: Progress toward harmonizing clinical data and connecting clinical and caregiver-reported data for neonatal hypoxic-ischemic encephalopathy

Publication Number: 1013.15

Betsy Pilon, Hope for HIE, West Bloomfield, MI, United States; Danielle Guez-Barber, University of Colorado School of Medicine, Aurora, CO, United States; Maggie Jalowsky, Hope for HIE, Detriot, MI, United States; Zachary A. Vesoulis, Washington University School of Medicine, St. Louis, MO, United States; Eric S. Peeples, University of Nebraska Medical Center, Omaha, NE, United States; Paul H. Gross, Cerebral Palsy Research Network, Greenville, SC, United States; Joyce P. Trost, Cerebral Palsy Research Network, Greenville, SC, United States

Background: Care for children after hypoxic-ischemic encephalopathy (HIE) is limited by the absence of systematically collected long-term outcomes and a focus on measures that overlook community priorities. Clinicians, researchers, and families alike emphasize the need for high-quality data to clarify outcomes, validate biomarkers, and guide new therapeutic strategies.

Objective: To integrate clinical and family-reported data to support longitudinal, multicenter research in neonatal HIE; evaluate the use of standardized data elements and shared electronic health record tools for harmonized, sustainable data collection; and assess the registry's potential to advance natural history studies, clinical trials, and family-centered outcomes in neonatal brain injury research.

Design/Methods: The HIE Registry is a community-driven, multicenter platform capturing longitudinal clinical and caregiver-reported data on infants with HIE. Launched in 2025, the pilot includes two sites with differing PI specialties-Neurology (University of Colorado) and Neonatology (Washington University in St. Louis). Clinical data were collected either prospectively through discrete Neurology consult note elements or retrospectively via informatics extraction, and linked with caregiver surveys capturing healthcare experiences, communication, and family support using a privacy-preserving Clinical Research Identifier (CRID).

Results: Results demonstrate successful multisite implementation and integration of clinical and family-reported data. The clinical registry included 38 elements detailing perinatal events, clinical management, neuroimaging, and EEG findings, with 22 prospectively enrolled patients at Colorado and 463 retrospectively collected at WashU. The community registry enrolled 15 caregivers; 14 generated linked CRIDs, and 10 completed NICU experience surveys.

Conclusion(s): The HIE Registry demonstrates the feasibility of harmonizing multisite data by integrating clinical and caregiver-reported information through shared tools such as standardized Epic forms. These approaches enhance efficiency, consistency, and clinical decision-making. Ongoing work will expand standardized data elements, extend collection beyond the NICU, and increase multilingual and site participation. By uniting clinical and family perspectives, the registry establishes a scalable foundation for natural history studies, clinical trials, quality improvement, and outcome measure development-highlighting the power of collaboration across academic, data, and family partners to advance care for children with neonatal HIE.

HIE Registry Structure
The HIE Registry integrates clinically entered data from two pilot sites using standardized neonatal core elements within the CPRN Clinical Registry and caregiver-reported data from the My HIE Journey Community Registry, capturing demographics and NICU experiences. Linked through a privacy-preserving identifier, this dual-data model connects clinical and family perspectives. Organizational and infrastructure partners include Hope for HIE, the Cerebral Palsy Research Network, and the Newborn Brain Society.

HIE Registry EHR Data Element Example
The HIE registry neonatal neurology consult template integrates structured neonatal core data elements into the electronic health record. Discrete fields capture perinatal events, delivery characteristics, resuscitation, therapeutic hypothermia, seizures/EEG, medications, and MRI findings. This structured form supports consistent, prospective data entry across sites, enables linkage with caregiver-reported data, and facilitates clinical decision-making and research-ready data collection within routine care workflows.