Infection; NewbornSPITSSNCT05490212
Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study
An observational study of Infection; Newborn, run by Tufts Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection; Newborn
- What is being tested?
- Single Molecule Array (SiMoA)
- How many people
- 5,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Oct 2019to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Neonates < 43 weeks' gestation, currently admitted to the NICU or well-baby nursery, who undergo a rule-out sepsis evaluation and are started on antibiotics.
Who may be able to join
- Neonates < 43 weeks' gestation, currently admitted to the NICU or well-baby nursery.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Liz Yen, MD, eyen@tuftsmedicalcenter.org
Anne Kurfiss, MPH, 617-636-7134, akurfiss@tuftsmedicalcenter.org
- Recruiting
University of Florida
Gainesville, Florida, 32610
James Wynn, MD, 352-294-5496, james.wynn@peds.ufl.edu
Carmen Thorton, RRT, 352-294-8642, carmenthornton@peds.ufl.edu
- Recruiting
Women and Infants' Hospital
Providence, Rhode Island, 02905
Joseph Bliss, MD, Phd, 401-274-1122, Jbliss@wihri.org
Steven Knapp, sknapp@wihri.org
About this study
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.
Read the detailed description
Specific Aim 1: Develop a predictive model of neonatal infection based upon the expression profile of six salivary inflammatory biomarkers, CRP, procalcitonin, tumor necrosis factor-alpha (TNF-α), and interleukins (IL) 1β, 6, and 8, within the first 36 hours of treatment. Serial saliva samples collected at the initiation of antibiotic therapy and 18-36 hours into treatment from 2,250 neonatal 'rule out sepsis' evaluations will undergo multiplexed quantification of the six salivary inflammatory biomarkers. Diagnostic accuracy will be calculated and predictive models will be developed, incorporating clinical, demographic, and biomarker data.
Specific Aim 2: Validate the predictive model of neonatal infection developed in Aim 1 on an external cohort of newborns. Serial saliva samples from an additional, prospective cohort of 1,750 infants undergoing a 'rule out sepsis' evaluation will be collected to test the validity of the predictive model for neonatal infection.
Specific 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. Salivary samples from the subset of uninfected newborns from Aims 1 and 2 will be combined and used to establish the 95% reference intervals of the salivary inflammatory biomarkers at each time point. Salivary profiles will be correlated to discharge diagnoses (i.e. bronchopulmonary dysplasia, periventricular leukomalacia) to assess the ability of each biomarker, alone and in combination, to predict neonatal morbidities known or hypothesized to be associated with an inflammatory response.
- Conditions
- Infection; Newborn
- Being tested
- Single Molecule Array (SiMoA)
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Molecule Array (SiMoA)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
confirmed (culture positive) infection
Measured: at initiation-of-rule-out, at 18-to-36-hour, and change between these time points
Secondary outcomes (1)
confirmed (culture positive) infection or clinical infection
Measured: at initiation-of-rule-out, at 18-to-36-hour, and change between these time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start3 Oct 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection; NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, University of Florida, Brigham and Women's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490212
- Sponsor's protocol ID
- 13372
- Acronym
- SPITSS
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set will be submitted to NIH.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study
- ClinicalTrials.gov ID
- NCT05490212
- Acronym / sponsor ID
- SPITSS / 13372
- Conditions
- Infection; Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, University of Florida, Brigham and Women's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aim 1: Develop a predictive model of neonatal infection based upon the expression profile of six salivary inflammatory biomarkers, CRP, procalcitonin, tumor necrosis factor-alpha (TNF-α), and interleukins (IL) 1β, 6, and 8, within the first 36 hours of treatment. Serial saliva samples collected at the initiation of antibiotic therapy and 18-36 hours into treatment from 2,250 neonatal 'rule out sepsis' evaluations will undergo multiplexed quantification of the six salivary inflammatory biomarkers. Diagnostic accuracy will be calculated and predictive models will be developed, incorporating clinical, demographic, and biomarker data.
Specific Aim 2: Validate the predictive model of neonatal infection developed in Aim 1 on an external cohort of newborns. Serial saliva samples from an additional, prospective cohort of 1,750 infants undergoing a 'rule out sepsis' evaluation will be collected to test the validity of the predictive model for neonatal infection.
Specific 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. Salivary samples from the subset of uninfected newborns from Aims 1 and 2 will be combined and used to establish the 95% reference intervals of the salivary inflammatory biomarkers at each time point. Salivary profiles will be correlated to discharge diagnoses (i.e. bronchopulmonary dysplasia, periventricular leukomalacia) to assess the ability of each biomarker, alone and in combination, to predict neonatal morbidities known or hypothesized to be associated with an inflammatory response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates < 43 weeks' gestation, currently admitted to the NICU or well-baby nursery, who undergo a rule-out sepsis evaluation and are started on antibiotics.
Key inclusion criteria (1 listed)
- Neonates < 43 weeks' gestation, currently admitted to the NICU or well-baby nursery.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
confirmed (culture positive) infection
Time frame: at initiation-of-rule-out, at 18-to-36-hour, and change between these time points
1 secondary outcome
confirmed (culture positive) infection or clinical infection
Time frame: at initiation-of-rule-out, at 18-to-36-hour, and change between these time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Yes. The de-identified data set will be submitted to NIH.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection; Newborn, run by Tufts Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Maron, MD, MPH (401-274-1100, JMaron@Wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.