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Microfluidic Assessment of Clinical Outcomes in Preterm Newborns

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ClinicalTrials.gov Identifier: NCT03291496
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Florida

Brief 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. 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.


Condition or disease Intervention/treatment
Neonatal SEPSIS Other: Blood Collection Preterm Other: Blood Collection Term Other: Adult Blood collection

Detailed Description:

Blood samples will be collected from two populations: preterm infants and term infants.

  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.

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Study Type : Observational
Estimated Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Preterm Neonates
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 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.
Other: 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
Other: Adult Blood collection
One Time 1 ml of whole blood collected




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neutrophil Function of Premature Neonate during Development [ Time Frame: Days 22-180 ]
    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


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   23 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Preterm neonates <32 weeks gestation. Term neonates >36 weeks gestation.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291496


Contacts
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Contact: Jessice Cline 352-294-8846 jessicalcline@peds.ufl.edu

Locations
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United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: James L Wynn, MD    352-273-8980    james.wynn@peds.ufl.edu   
Sub-Investigator: Lyle Moldawer, PhD         
Sub-Investigator: Russ Hawkins, MD         
Sponsors and Collaborators
University of Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: James L Wynn, MD University of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03291496    
Other Study ID Numbers: IRB201701566 N
R01HD089939 ( U.S. NIH Grant/Contract )
OCR26202 ( Other Identifier: OCR OnCore )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Sepsis
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes