Recruiting

Salivary Profiling

Sponsor:

Tufts Medical Center

Code:

NCT05490212

Conditions

Infection; Newborn

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Single Molecule Array (SiMoA)

Study Details

Brief 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

Study ID

NCT05490212

Start date

Oct 3, 2019

Status verified date

Aug, 2022

Completion date

May 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 or other non-infectious, life-limiting illness, known at the time parents would be approached for consent.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • confirmed (culture positive) infection [ Time Frame: at initiation-of-rule-out, at 18-to-36-hour, and change between these time points ]

Central Contacts and Locations

Central contacts

Jill Maron, MD, MPH

401-274-1100JMaron@Wihri.org

Anne Kurfiss, MPH

617-636-7134akurfiss@tuftsmedicalcenter.org

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

James Wynn, MD

352-294-5496james.wynn@peds.ufl.edu

Carmen Thorton, RRT

352-294-8642carmenthornton@peds.ufl.edu

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Liz Yen, MD

eyen@tuftsmedicalcenter.org

Anne Kurfiss, MPH

617-636-7134akurfiss@tuftsmedicalcenter.org

Women and Infants' Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Joseph Bliss, MD, Phd

401-274-1122Jbliss@wihri.org

Steven Knapp

sknapp@wihri.org

More Information

Sponsor

Tufts Medical Center

Last update posted

Aug 5, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2022-08-05.