Background and objectives: 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 collected by all 22 international NE/HIE registries: birth weight, gestational age, and 1- and 5-minute Apgar scores. In response, our team set out to develop a set of common inpatient data elements to enable future harmonization of NE/HIE registry data.
Methods: Using a modified Delphi method, a panel of 14 international NE experts voted to separate the 1,281 variables from our previous study into "core elements," "supplemental elements," or those that "do not need to be collected." Based on the anonymous survey results, we created draft lists of core and supplemental common data elements (CDEs). These lists were further revised through group consensus meetings and external feedback from global registry leaders and attendants at 2 international conferences.
Results: The final data forms include 164 core elements and 225 supplemental elements stratified into 11 domains: demographics; pregnancy, labor, and delivery; delivery room; transport; acid-base; therapeutic hypothermia; neuromonitoring and seizures; neuroimaging; laboratory values (other than acid-base); hospital course; and discharge.
Discussion: The CDEs are the first of several important steps to further standardize research and reporting of NE/HIE investigations to perform more efficient and powerful clinical research in the field moving forward. Future studies need to establish a clinical and research definition of HIE and develop CDEs for collecting long-term, family-centered follow-up data postdischarge.
Eric S Peeples, Ulrike Mietzsch, Eleanor J Molloy, Betsy Pilon, Danielle Guez-Barber, Janet Soul, Khorshid Mohammad, Gabrielle deVeber, Vann Chau, Sonia Lomeli Bonifacio, Alexa Kanwit Craig, Jehier Afifi, Hemmen Sabir, Floris Groenendaal, Eilon Shany, Maria L V Dizon, Osuke Iwata, Emel Okulu, Agnes Jermendy, Nem Yun Boo, Mohamed El-Dib, Pia Wintermark; Newborn Brain Society Guidelines and Publications Committee
Disease Category: Neurology
Disease Name: Neonatal Encephalopathy
Age Range: 0 - 1
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Registry experts
- Researchers
- Minimum dataset for registries
- Consensus meeting
- Delphi process
- Literature review