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

NCT05490212 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2022-08-05

No results posted yet for this study

Summary

The aim 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 (cytokines) 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 tests currently being used.

Conditions

  • Infection; Newborn

Interventions

OTHER

Single Molecule Array (SiMoA)

The Single Molecule Array (SiMoA), capable of quantifying multiple salivary cytokines from a single sample source at a femtoscale level. The SiMoA platform has been adapted to detect up to nine inflammatory biomarkers, including CRP, PCT, tumor necrosis factor α (TNF α) and ILs 1ß, 6, and 8 in neonatal saliva.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Tufts Medical Center

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490212 on ClinicalTrials.gov