Serum neuron-specific enolase as a prognostic predictor in newborns with hypoxic-ischemic encephalopathy

Abstract

BACKGROUND: Hypoxic-ischemic encephalopathy (HIE) stands as an important cause of mortality and neurological morbidity in full-term newborns. While there are established techniques for HIE prognosis, such as clinical evaluation, amplitude-integrated electroencephalogram (aEEG), and magnetic resonance imaging (MRI), they are not clearly effective indicators for an early prognosis of neurodevelopment in newborns with HIE. Thus, this study aims to evaluate the predictive value of neuron-specific enolase (NSE), a biomarker of neuronal damage in the central nervous system (CNS), for the neurological outcomes in newborns with HIE. OBJECTIVES: The main objective is to determine whether serum levels of NSE serve as a prognostic predictor for neurodevelopmental outcome in newborns with HIE. DESIGN AND METHODS: Structured as a multicentric, prospective observational descriptive study, this is a prognostic tool accuracy study, which will be settled in the Neonatal Intensive Care Unit (NICU) of six hospitals of Catalunya. NSE serum values will be determined during the newborn’s hospitalization period, and the obtained results will be compared to the neurodevelopmental outcome, assessed through the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III score) at 18 months from birth. The sensitivity of NSE serum values to predict a favorable or unfavorable outcome will be evaluated along with other measurements, such as specificity, positive and negative predictive values, likelihood ratio and diagnostic accuracy. Also, NSE serum values will be associated with the well-established and routine prognostic techniques, including clinical assessment, aEEG and MRI. STUDY PARTICIPANTS: 90 full-term newborns diagnosed with HIE within the first 6 hours of life will be consecutively recruited over an estimated period of 1 year from the NICU of Hospital Universitari Josep Trueta (HUJT), Hospital Sant Joan de Déu (HSJD), Hospital Universitari Vall d’Hebron (HUVH), Hospital Universitari Germans Trias i Pujol (HUGTP), Hospital Universitari Parc Taulí (HUPT) and Hospital Universitari Joan XXIII (HUJ23).