Neonatal SEPSISNCT03291496
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
An observational study of Neonatal SEPSIS, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal SEPSIS
- What is being tested?
- Blood Collection Preterm, Blood Collection Term and Adult Blood collection
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 23 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm neonates <32 weeks gestation. Term neonates >36 weeks gestation.
Who may be able to join
- For preterm neonates <32 weeks gestation at birth with no known or suspected congenital anomalies.
- For term neonates >36 weeks gestation at birth with no known or suspected congenital anomalies.
Who cannot join
- Congenital defects, suspected genetic disorders, 32-36 weeks completed gestation, or lack of consent.
- Healthy Adult:
- Inclusion criteria Between the ages of 18 and 65 years of age
- Exclusion Criteria Taking any immune modifying medications or have an active immune modifying disease process
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Blood samples will be collected from two populations: preterm infants and term infants.
- Preterm neonates (<32 weeks) the study team will collect a baseline 250 µl blood sample on day four of life and then approximately every three days, as is possible, until twenty-one days of life. In addition, for preterm neonates who have suspected sepsis, an additional 250 µl blood sample will be obtained on the day of suspected sepsis. After day twenty-one of life, 250 µl blood will be sampled one time per week until discharge, when a final 250 µl blood sample will be collected. The amount drawn for study related blood collections will not exceed the lesser of 50 ml or 3.0 ml/kg in an 8-week period.
- Term neonates (>36 weeks) the study team will be collect a single 250 µl blood sample with the routine screen for metabolic disorders when they are >24 hours old. This will be the only study related blood collection for term neonates.
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.
- Conditions
- Neonatal SEPSIS
- Being tested
- Blood Collection Preterm, Blood Collection Term, Adult Blood collection
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Collection PretermOther
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.
Blood Collection TermOther
A single 250 µl blood sample will be collected once the term neonate is >24 hours old.
Adult Blood collectionOther
One Time 1 ml of whole blood collected
| Study group | Role | What they receive |
|---|---|---|
| Preterm Neonates | Blood collection Preterm. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured. Receives: Other: Blood Collection Preterm | |
| Term Neonates | Blood collection Term. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured. Receives: Other: Blood Collection Term | |
| Healthy Adult | One-time whole blood draw of 1ml collection Receives: Other: Adult Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 4-21
Secondary outcomes (1)
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
Measured: Days 22-180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start14 Nov 2017
- Primary completion10 May 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James L Wynn, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291496
- Sponsor's protocol ID
- IRB201701566 N
- Other IDs
- R01HD089939, OCR26202
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2017
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125INIS Collaborative Group; Brocklehurst P, Farrell B, King A, Juszczak E, Darlow B, Haque K, Salt A, Stenson B, Tarnow-Mordi W. Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med. 2011 Sep 29;365(13):1201-11. doi: 10.1056/NEJMoa1100441.
PubMed 21962214Barton L, Hodgman JE, Pavlova Z. Causes of death in the extremely low birth weight infant. Pediatrics. 1999 Feb;103(2):446-51. doi: 10.1542/peds.103.2.446.
PubMed 9925839Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
PubMed 20732945Martin GS, Mannino DM, Moss M. The effect of age on the development and outcome of adult sepsis. Crit Care Med. 2006 Jan;34(1):15-21. doi: 10.1097/01.ccm.0000194535.82812.ba.
PubMed 16374151Cohen-Wolkowiez M, Moran C, Benjamin DK, Cotten CM, Clark RH, Benjamin DK Jr, Smith PB. Early and late onset sepsis in late preterm infants. Pediatr Infect Dis J. 2009 Dec;28(12):1052-6. doi: 10.1097/inf.0b013e3181acf6bd.
PubMed 19953725Watson RS, Carcillo JA. Scope and epidemiology of pediatric sepsis. Pediatr Crit Care Med. 2005 May;6(3 Suppl):S3-5. doi: 10.1097/01.PCC.0000161289.22464.C3.
PubMed 15857554Girard TD, Opal SM, Ely EW. Insights into severe sepsis in older patients: from epidemiology to evidence-based management. Clin Infect Dis. 2005 Mar 1;40(5):719-27. doi: 10.1086/427876. Epub 2005 Jan 28.
PubMed 15714419Haque KN, Khan MA, Kerry S, Stephenson J, Woods G. Pattern of culture-proven neonatal sepsis in a district general hospital in the United Kingdom. Infect Control Hosp Epidemiol. 2004 Sep;25(9):759-64. doi: 10.1086/502473.
PubMed 15484801Martinot A, Leclerc F, Cremer R, Leteurtre S, Fourier C, Hue V. Sepsis in neonates and children: definitions, epidemiology, and outcome. Pediatr Emerg Care. 1997 Aug;13(4):277-81. doi: 10.1097/00006565-199708000-00011. No abstract available.
PubMed 9291519Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
PubMed 15547163Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Changes in pathogens causing early-onset sepsis in very-low-birth-weight infants. N Engl J Med. 2002 Jul 25;347(4):240-7. doi: 10.1056/NEJMoa012657.
PubMed 12140299Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.
PubMed 12165580Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.
PubMed 22682464Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006 Jun;117(6):1979-87. doi: 10.1542/peds.2005-1707.
PubMed 16740839
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
- ClinicalTrials.gov ID
- NCT03291496
- Acronym / sponsor ID
- IRB201701566 N
- Conditions
- Neonatal SEPSIS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2017 (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.
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.
Detailed description
Blood samples will be collected from two populations: preterm infants and term infants.
- Preterm neonates (<32 weeks) the study team will collect a baseline 250 µl blood sample on day four of life and then approximately every three days, as is possible, until twenty-one days of life. In addition, for preterm neonates who have suspected sepsis, an additional 250 µl blood sample will be obtained on the day of suspected sepsis. After day twenty-one of life, 250 µl blood will be sampled one time per week until discharge, when a final 250 µl blood sample will be collected. The amount drawn for study related blood collections will not exceed the lesser of 50 ml or 3.0 ml/kg in an 8-week period.
- Term neonates (>36 weeks) the study team will be collect a single 250 µl blood sample with the routine screen for metabolic disorders when they are >24 hours old. This will be the only study related blood collection for term neonates.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preterm Neonates | – | Other: Blood Collection PretermBlood collection Preterm. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured. |
| Term Neonates | – | Other: Blood Collection TermBlood collection Term. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured. |
| Healthy Adult | – | Other: Adult Blood collectionOne-time whole blood draw of 1ml collection |
Who may qualify
- Ages
- 23 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm neonates <32 weeks gestation. Term neonates >36 weeks gestation.
Key inclusion criteria (2 listed)
- For preterm neonates <32 weeks gestation at birth with no known or suspected congenital anomalies.
- For term neonates >36 weeks gestation at birth with no known or suspected congenital anomalies.
Key exclusion criteria (4 listed)
- Congenital defects, suspected genetic disorders, 32-36 weeks completed gestation, or lack of consent.
- Inclusion criteria Between the ages of 18 and 65 years of age
- Exclusion Criteria Taking any immune modifying medications or have an active immune modifying disease process
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 |
|---|---|---|
| Blood Collection PretermBlood 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. | Other | Preterm Neonates |
| Blood Collection TermA single 250 µl blood sample will be collected once the term neonate is >24 hours old. | Other | Term Neonates |
| Adult Blood collectionOne Time 1 ml of whole blood collected | Other | Healthy Adult |
Primary outcome
Prediction of Sepsis in Premature Neonates
Time frame: Days 4-21
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.
1 secondary outcome
Neutrophil Function of Premature Neonate during Development
Time frame: Days 22-180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 22579125Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Background: PubMed 21962214INIS Collaborative Group; Brocklehurst P, Farrell B, King A, Juszczak E, Darlow B, Haque K, Salt A, Stenson B, Tarnow-Mordi W. Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med. 2011 Sep 29;365(13):1201-11. doi: 10.1056/NEJMoa1100441.
- Background: PubMed 9925839Barton L, Hodgman JE, Pavlova Z. Causes of death in the extremely low birth weight infant. Pediatrics. 1999 Feb;103(2):446-51. doi: 10.1542/peds.103.2.446.
- Background: PubMed 20732945Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
- Background: PubMed 16374151Martin GS, Mannino DM, Moss M. The effect of age on the development and outcome of adult sepsis. Crit Care Med. 2006 Jan;34(1):15-21. doi: 10.1097/01.ccm.0000194535.82812.ba.
- Background: PubMed 19953725Cohen-Wolkowiez M, Moran C, Benjamin DK, Cotten CM, Clark RH, Benjamin DK Jr, Smith PB. Early and late onset sepsis in late preterm infants. Pediatr Infect Dis J. 2009 Dec;28(12):1052-6. doi: 10.1097/inf.0b013e3181acf6bd.
- Background: PubMed 15857554Watson RS, Carcillo JA. Scope and epidemiology of pediatric sepsis. Pediatr Crit Care Med. 2005 May;6(3 Suppl):S3-5. doi: 10.1097/01.PCC.0000161289.22464.C3.
- Background: PubMed 15714419Girard TD, Opal SM, Ely EW. Insights into severe sepsis in older patients: from epidemiology to evidence-based management. Clin Infect Dis. 2005 Mar 1;40(5):719-27. doi: 10.1086/427876. Epub 2005 Jan 28.
- Background: PubMed 15484801Haque KN, Khan MA, Kerry S, Stephenson J, Woods G. Pattern of culture-proven neonatal sepsis in a district general hospital in the United Kingdom. Infect Control Hosp Epidemiol. 2004 Sep;25(9):759-64. doi: 10.1086/502473.
- Background: PubMed 9291519Martinot A, Leclerc F, Cremer R, Leteurtre S, Fourier C, Hue V. Sepsis in neonates and children: definitions, epidemiology, and outcome. Pediatr Emerg Care. 1997 Aug;13(4):277-81. doi: 10.1097/00006565-199708000-00011. No abstract available.
- Background: PubMed 15547163Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
- Background: PubMed 12140299Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Changes in pathogens causing early-onset sepsis in very-low-birth-weight infants. N Engl J Med. 2002 Jul 25;347(4):240-7. doi: 10.1056/NEJMoa012657.
- Individual participant dataSharing planned: Undecided
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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.
James L Wynn, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by University of Florida at 1 site 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Sepsis in Premature Neonates (time frame: Days 4-21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291496, which also lists 33 linked publications.
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 13 Feb 2026.