An observational study in Neonatal SEPSIS, sponsored by University of Florida. Active, not recruiting at 1 site in United States. Open to participants aged 23 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of Florida · Observational
Among 15 studies in Neonatal Sepsis with a site in United States — 2 open to participants now, 3 under way, none of them phase 3. Neonatal Sepsis · United States.
Among the 15 studies in Neonatal Sepsis with a site in United States, this one is the only one that started in 2017, is one of 7 observational ones, and was the 7th registered.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
Browse Neonatal Sepsis studies →2 of the 15 studies in Neonatal Sepsis with a site in United States are open now. Recruiting first, the newest first:
Children's Hospital of Philadelphia · Sites in United States
Mount Sinai Hospital, Canada · Sites in United States, Canada, Ireland and 2 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Neonatal Sepsis studies recruiting now, 8 (35%) set no upper age limit and 15 (65%) stop at 75 or younger; 20 take children under 18; 2 take healthy volunteers.
This study: 23 Weeks to 42 Weeks · all sexes · healthy volunteers too.
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15 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2017.
This study's enrollment of 293 is above the median of 200 across 85 observational studies indexed under Neonatal Sepsis.
Median enrollment 23 across the 8 interventional studies, 293 across the 7 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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2 of 15 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 1 study filed under Neonatal Sepsis — fewer than ten, so there is no comparison to draw.
2 of the studies in Neonatal Sepsis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05347238Mount Sinai Hospital, CanadaDopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis | 2027-06-30 |
| NCT06772675Children's Hospital of PhiladelphiaVancomycin Reduction Practices (VRP) in the NICU | 2027-09 |
Among the 15 studies in Neonatal Sepsis with a site in United States, from their registry updates:
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Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis (sepsis within the first month of life) causes over one million deaths worldwide annually, and is one of the most common, difficult and costly problems to diagnose, treat and prevent. The preterm infant can suffer rates of sepsis up to 1000-fold higher than the full-term infant, and bears the brunt of the associated mortality and lifelong sepsis-survivor morbidity.
The project is enabled by several novel, validated, microfluidic technologies that are robust and easy to use with little training. These technologies provide comprehensive measures of the functionality of blood PMN population; a critical cellular component of innate immunity. The study team will also extract high-quality nucleic acids from microfluidic-sorted PMNs for transcriptomic analyses. Collectively, these techniques require a total of 250 microliters (µL) of blood, which makes them particularly useful for preterm infants where sample volume is limited, and facilitates serial assessments with unprecedented temporal resolution of key functions of PMNs.
These studies, integrated with bioinformatics approaches, will generate new tools for diagnosing sepsis in the newborn and predicting clinical outcomes. Such approaches have the capability to dramatically change the clinical management of the preterm infant, and potentially improve long-term outcomes while reducing hospital costs.
Blood samples will be collected from two populations: preterm infants and term infants.
For all infants, term and preterm, the following data will be collected while the neonate is hospitalized: Demographic information (age, date of birth), past and present medical records, laboratory, microbiology, and all other test results, X-ray, CT, MRI, US and all other imaging test results, records about any medication received during admission, records of physical exam during admission, records of all vital signs and hemodynamic monitoring during admission, records of any procedure or intervention during admission, and condition at the discharge and discharge location.
Preterm neonates \<32 weeks gestation. Term neonates >36 weeks gestation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Healthy Adult:
Blood collection Preterm. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured.
Other: Blood Collection Preterm
Blood collection Term. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured.
Other: Blood Collection Term
One-time whole blood draw of 1ml collection
Other: Adult Blood collection
Blood will be collected on day 4 of life and then approximately every 3 days until 21 days of life. Thereafter, one sample will be collected weekly until discharge. For preterm neonates that have suspected sepsis an additional sample will be collected within 24-48 hours of the initial sepsis evaluation.
A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.
One Time 1 ml of whole blood collected
Prediction of Sepsis in Premature Neonates
The study team will determine whether blood neutrophil migration phenotype using a microfluidic-based approach can be used to predict the onset of sepsis, as well as poor outcome from sepsis, in premature neonates. From peripheral blood, the study team will measure speed, directionality, and persistence of neutrophil chemotaxis using microfluidic devices. The goal is to prospectively identify and validate biomarkers that can stratify neonates who will become septic and have a protracted clinical course. To complement these functional assays, the study team will determine if transcriptomic profiling adds to the diagnostic resolution generated through these functional analyses.
Time frame: Days 4-21
Neutrophil Function of Premature Neonate during Development
The study team will determine whether premature neonates restore a more normal neutrophil migration phenotype and genomic profile as they reach their developmental milestones during NICU admission
Time frame: Days 22-180
Plan to share: Undecided
Ran from Nov 2017 to primary completion in May 2022, 53 months.
Of 37 non-industry observational studies under Neonatal Sepsis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's 53 months is above that.
Counting every sponsor, half of 38 studies reached it within 25 months; a quarter within 16 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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