Microfluidic Assessment of Clinical Outcomes in Preterm Newborns

NCT03291496 | Active Not Recruiting

• 3 other identifiers: IRB201701566 NR01HD089939OCR26202
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal SEPSIS

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 4-21

Secondary Outcomes (1)

• Neutrophil Function of Premature Neonate during Development

  Days 22-180

Study Arms (3)

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

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

Healthy Adult

One-time whole blood draw of 1ml collection

Other: Adult Blood collection

Interventions

Blood Collection Preterm OTHER

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.

Preterm Neonates

Blood Collection Term OTHER

A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.

Term Neonates

Adult Blood collection OTHER

One Time 1 ml of whole blood collected

Healthy Adult

Eligibility Criteria

• Age: 23 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm neonates \<32 weeks gestation. Term neonates \>36 weeks gestation.

You may qualify if:

• 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.

You may not qualify if:

• Congenital defects, suspected genetic disorders, 32-36 weeks completed gestation, or lack of consent.
• Healthy Adult:

Sponsors & Collaborators

• University of Florida: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Related Publications (33)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James L Wynn, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: November 14, 2017
• Primary Completion: May 10, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)