Assistant Professor Hackensack Meridian School of Medicine Hackensack Meridian Health School of Medicine Teaneck, New Jersey, United States
Background: The dynamic evolution in neurologic examination findings coupled with the need to initiate therapeutic hypothermia within the first 6 hours of life presents challenges in using clinical examination to identify newborns with mild HIE. Serial examinations are recommended with a threshold effect for decision making. The research gap in mild HIE is compounded by both the dynamic evolution and overlap between mild and moderate asphyxia, as well as the lack of a clear and consistent definition of what constitutes mild HIE in the first 6 hours of life whereby decisions regarding therapies are made. Objective: Establishing a standardized protocol including a neurological examination incorporating NIRS and aEEG will help to detect subtle neurological exam changes in this previously thought normal homogenous population. Following our proposed algorithm will help to diagnose infants with mild HIE within a therapeutic window of 6 hours. Design/Methods: IRB approved,single center,prospective pilot study of inborn infants with cord gas or postnatal gas pH < 7.0 and/or base excess ≥12 mmol/L. Patients with birth anomalies, birth weight < 1800g, or moderate or severe NE will be excluded. Enrollment will be done within one hour of life after obtaining cord blood gas. Infants will be closely monitored in the NICU for 6 hours with aEEG, NIRS, and serial neurological exams with a scoring system using the modified Sarnat. We are currently in the process of enrolling patients. To gather data on 2 non-invasive methods for hypothesis generation, not hypothesis testing a sample size of 40 patients will be sufficient to look for relationships between the standard of care and proposed neuromonitoring. Exploratory data analysis will be utilized to understand the relationships between aEEG, NIRS and standard of care results among acidotic infants using univariate and bivariate analysis. Descriptive statistics will be used to summarize the data and group comparisons will be explored using ANOVA or Pearson’s chi-squared test with a significance threshold of 0.05 followed by appropriate pairwise tests.
