The goal of this study is to develop a faster, safer, and more accurate method for determining if a newborn has an infection. This study involves analyzing saliva for markers of infection and inflammation known as cytokines. We will analyze infant’s saliva repeatedly for inflammatory biomarkers within the first 36 hours of their standard of care treatment. We hypothesize that levels of these cytokines will more quickly predict which babies are truly infected and which babies are not compared to the blood test currently being used.
The aims of the study are:
- Aim 1: Develop a predictive model of neonatal infection based pon the expression profile of six salivary inflammatory biomarkers (C-reactive protein/CRP, procalcitonin/PCT, tumor necrosis factor-alpha/TNF-α, interleukin (IL) 1-beta/IL1β, IL6, and IL8, within the first 36 hours of treatment.
- Aim 2: Validate the predictive model of neonatal infection developed in Aim 1 on an external cohort of newborns.
- Aim 3: Establish normative salivary reference ranges of the inflammatory biomarkers across varying gestational ages and weights and assess the potential of these biomarkers to predict other neonatal morbidities.
