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Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study

All genders

No minimum age

Recruiting now


Principal Investigator: Elizabeth Yen, MD

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.

Contact Us

Anne Kurfiss, MPH

Study details

Inclusion Criteria
  • Neonates < 43 weeks' gestation
  • Currently admitted to the NICU or well-baby nursery
Exclusion Criteria
  • Neonates suffering from a lethal genetic or chromosomal abnormality
  • Neonates suffering from non-infectious, life-limiting illness, known at the time parents are approached for consent.
Study Requirements

Saliva samples will be serially collected from any infants undergoing routine blood evaluation for a suspected infection. Samples are acquired within the first 36 hours of this standard care. Parental informed consent will be obtained before saliva samples are analyzed using single molecule array (SiMoA) technology, which is capable of quantifying multiple salivary cytokines from a single sample source at a femtoscale level.

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