The Registry for Neonatal Encephalopathy

Methods

The Registry is maintained at the Vermont Oxford Network in Burlington, VT.

Hospital Eligibility: In the pilot year, 2006, all hospitals in the Vermont Oxford Network Expanded Database will be eligible. In subsequent years, eligibility may be expanded to include all hospitals participating in the Vermont Oxford Network.

Infant Eligibility: 36 weeks gestation or more with evidence of neonatal encephalopathy within 3 days of birth defined as presence of seizures and/or altered consciousness (stupor, coma).

Data Collection and Monitoring: Data are collected and submitted using the Vermont Oxford Network eNICQ software. A special data module for the eNICQ application has been developed to support collection, editing, and electronic submission of data to the Registry.

Internet Conferences: Participants in the Registry are eligible to participate in the iNICQ Encephalopathy Collaborative, a series of interactive Internet conferences (Webex) designed to assist multidisciplinary teams to improve the quality and safety of care for infants with encephalopathy and their families. These educational sessions which will include expert presentations on neonatal encephalopathy will be an additional benefit of participation. They will also provide an interactive forum for collaboration with colleagues around the world.

Routine Reporting to Participating Hospitals: Participating hospitals will receive reports comparing their own data with those of all hospitals participating in the Registry.

Observational Research: The Registry will be used to perform observational research including describing the population of infants with encephalopathy, associated perinatal factors, medical treatments, co-morbidities and outcomes. There will be an opportunity to link the Registry with ongoing Network efforts to track neurodevelopmental outcomes using simple parent questionnaires. A planned focus of the observational research will be to monitor the introduction and dissemination of new neuroprotective therapies such as hypothermia, assess selection criteria for neuroprotective therapy, and to identify variations in routine practices and outcomes. Each observational study will have a specific analytic plan and require approval by the Steering Committee.

Quality Improvement Opportunities: Data from the Registry will be used to identify opportunities for improvements in the quality and safety of the diagnosis, care and follow-up of infants with neonatal encephalopathy. These opportunities will be explored through the Vermont Oxford Network NICQ and iNICQ Quality Improvement Collaboratives. Case studies of improvements will be disseminated at the Network’s Annual Quality Congress for Neonatology and through interactive Internet conferences.

Planning for Prospective Research: Individual hospitals care for relatively few infants each year with neonatal encephalopathy. Many of these infants are born at outlying hospitals and often there is significant delay between birth and transfer to a referral center. These factors present challenges to the design and performance of multi-center studies of interventions for neonatal encephalopathy. The Registry will provide valuable information for generating hypotheses for prospective studies and randomized trials, and for estimating the sample sizes and feasibility of such studies.

Human Subjects: The Registry will be reviewed by the IRB at the University of Vermont and by the IRBs at the participating hospitals.