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Novel Mechanisms and Approaches to Treat Neonatal Sepsis

NCT02554630 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2023-02-10

No results posted yet for this study

Summary

Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700 million in the US alone.

In an effort to help mature the neonatal immune system, several adjuvant therapies have been studied; however, none have been implemented in clinical practice. One of the most frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a viable approach to reducing the incidence of early and late sepsis.

This research study will characterize immune genomic expression and functional capacity at the time of birth in both term and preterm neonates and determine what effects, if any, that adjuvants have on this function. Additionally, this study will seek to determine if immune function correlates with certain microbiota.

Conditions

  • Complication of Prematurity
  • Immunologic Deficiency Syndromes

Interventions

OTHER

Adjuvant

Blood will be incubated, ex-vivo, with one of the adjuvant therapies or no adjuvant and then, using microfluidic techniques the immune genomic profile and the functional capacity of immune cells will be assessed.

OTHER

Blood Collection

Blood collection will be performed on all groups.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Surgical Infection Society

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Shawn Larson, MD · University of Florida

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2022-10-21
Completion
2022-10-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554630 on ClinicalTrials.gov