360 - Developing Inpatient Common Data Elements for Neonatal Encephalopathy Research

Publication Number: 360.4097

Eric S. Peeples, University of Nebraska Medical Center, Omaha, NE, United States; Ulrike Mietzsch, University of Washington School of Medicine, Seattle, WA, United States; Eleanor J J. Molloy, Trinity College, Paediatrics and Child Health, Dublin, Dublin, Ireland; Betsy Pilon, Hope for HIE, West Bloomfield, MI, United States; Danielle Guez-Barber, Children's Hospital Colorado, Aurora, CO, United States; Janet Soul, Boston Children's Hospital, Boston, MA, United States; Khorshid Mohammad, University of Calgary, Calgary, AB, Canada; GABRIELLE A. DEVEBER MIKULIS, Hospital for Sick Children, Toronto, oakville, ON, Canada; Vann Chau, The Hospital for Sick Children and University of Toronto, Toronto, ON, Canada; Sonia L. Bonifacio, Stanford University School of Medicine, Los Altos, CA, United States; Alexa K. Craig, The Barbara Bush Children's Hospital at Maine Medical Center, Scarborough, ME, United States; Jehier Afifi, Dalhousie University Faculty of Medicine, Halifax, NS, Canada; Hemmen Sabir, University Hospital Bonn, Bonn, Nordrhein-Westfalen, Germany; Pia Wintermark, McGill University, Montreal, PQ, Canada

Background: Neonatal encephalopathy (NE) – including hypoxic-ischemic encephalopathy (HIE) – is associated with significant morbidity and mortality worldwide. While data registries provide hypothesis-generating data, aid in quality improvement and track management/outcomes over time, we recently demonstrated that only 4 of 1,281 (0.3%) variables were consistently collected among 22 international NE/HIE registries. Our team developed this study in response to that substantial variability.

Objective: To develop a set of common inpatient data elements to enable future harmonization of NE/HIE registry data.

Design/Methods: Using a modified Delphi method with a panel of 14 international NE/HIE experts, the 1,281 variables identified in our preliminary study were divided into 9 topical RedCap surveys for anonymous ranking (“core”, “supplemental”, or “does not need to be collected”) by panel members. Based on survey results, we created draft lists: Core (≥50% of panel selected core and < 3 selected “does not need to be collected”), Supplemental ( < 50% of panel selected core and < 3 selected “does not need to be collected”), or Do Not Collect (≥3 experts selected “does not need to be collected”). These lists were further revised through group consensus meetings and the final versions were used to generate draft data collection forms. Panelists then provided written feedback on the draft forms, which were ultimately finalized by group consensus in a series of video conference meetings.

Results: The team pared the 1,281 collected variables down to a total of 191 core elements divided into 11 data forms: 18 elements in Demographics; 36 in Pregnancy, Labor and Delivery; 21 in Delivery Room Management and Outcomes; 10 in Transport; 7 in Acid/Base; 19 in Therapeutic Hypothermia; 7 in Neuromonitoring and Seizures; 15 in Laboratory Results; 23 in Neuroimaging; 13 in Hospital Course; and 22 in Discharge. The feedback period for public comment will be open during the 2025 PAS Meeting and will remain open for 30 days following the meeting.

Conclusion(s): Public feedback from international registry leaders, participants, and the broader NE/HIE research community will be vital to validate these elements and secure public support. Improved data harmonization will allow future NE/HIE data sets to be combined, helping to improve national and international NE/HIE research and quality improvement. Future work will need to develop similar elements for post-discharge follow up for this population.