Novel Mechanisms and Approaches to Treat Neonatal Sepsis
Completed
Conditions studied: Complication of Prematurity, Immunologic Deficiency Syndromes
In brief
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.
Key facts
- Study ID
- NCT02554630
- Run by
- University of Florida
- People needed
- 142
- Starts
- 2016-02-01
- Expected to finish
- 2022-10-21
- Last updated by the study team
- 2023-02-10
Who can join
Age: any, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Consent to participate in the study
You may not qualify if…
- non- survivable condition
- Healthy Adult Controls
- Inclusion Criteria:
- Consent to participate in the study
- Age >18 years old, <55 years old
- Exclusion Criteria:
- Age <18 years old, >55 years old
- Severe pre-existing organ dysfunction
- Oncolytic therapy within 14 days
- HIV positive status
- Current use of chronic steroids
Where it is running
- UF Health — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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