Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
NCT ID: NCT03291496
Last Updated: 2025-04-22
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
293 participants
OBSERVATIONAL
2017-11-14
2025-12-31
Brief Summary
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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.
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Detailed Description
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1. 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.
2. 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm Neonates
Blood collection Preterm. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured.
Blood Collection Preterm
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.
Term Neonates
Blood collection Term. From blood, the speed, directionality, and persistence of PMN chemotaxis using microfluidic devices and transcriptomic analysis will be measured.
Blood Collection Term
A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.
Healthy Adult
One-time whole blood draw of 1ml collection
Adult Blood collection
One Time 1 ml of whole blood collected
Interventions
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Blood Collection Preterm
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 Term
A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.
Adult Blood collection
One Time 1 ml of whole blood collected
Eligibility Criteria
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Inclusion Criteria
* For term neonates \>36 weeks gestation at birth with no known or suspected congenital anomalies.
Exclusion Criteria
Healthy Adult:
23 Weeks
42 Weeks
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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James L Wynn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health
Gainesville, Florida, United States
Countries
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References
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Blencowe 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.
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Hill DA, Hoffmann C, Abt MC, Du Y, Kobuley D, Kirn TJ, Bushman FD, Artis D. Metagenomic analyses reveal antibiotic-induced temporal and spatial changes in intestinal microbiota with associated alterations in immune cell homeostasis. Mucosal Immunol. 2010 Mar;3(2):148-58. doi: 10.1038/mi.2009.132. Epub 2009 Nov 25.
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Wynn JL, Neu J, Moldawer LL, Levy O. Potential of immunomodulatory agents for prevention and treatment of neonatal sepsis. J Perinatol. 2009 Feb;29(2):79-88. doi: 10.1038/jp.2008.132. Epub 2008 Sep 4.
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Wynn JL, Guthrie SO, Wong HR, Lahni P, Ungaro R, Lopez MC, Baker HV, Moldawer LL. Postnatal Age Is a Critical Determinant of the Neonatal Host Response to Sepsis. Mol Med. 2015 Jun 2;21(1):496-504. doi: 10.2119/molmed.2015.00064.
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Wong HR, Freishtat RJ, Monaco M, Odoms K, Shanley TP. Leukocyte subset-derived genomewide expression profiles in pediatric septic shock. Pediatr Crit Care Med. 2010 May;11(3):349-55. doi: 10.1097/PCC.0b013e3181c519b4.
Wynn JL, Wong HR. Pathophysiology and treatment of septic shock in neonates. Clin Perinatol. 2010 Jun;37(2):439-79. doi: 10.1016/j.clp.2010.04.002.
Other Identifiers
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OCR26202
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201701566 N
Identifier Type: -
Identifier Source: org_study_id
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