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NCT02554630 · ClinicalTrials.gov registry record

Novel Mechanisms and Approaches to Treat Neonatal Sepsis

A clinical trial, sponsored by University of Florida.

Completed
Registry status
142
Enrollment target

NCT02554630 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 142 participants.

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The verdict

NCT02554630 has completed, sponsored by University of Florida.

COMPLETED
Registry status
142 participants
Enrollment target

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.

Interventions

  • OTHER Blood Collection
  • OTHER Adjuvant

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2016-02
Est. Completion 2022-10-21

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT02554630

The ClinicalTrials.gov registry entry for NCT02554630 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Blood Collection is the first listed.

NCT02554630 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02554630 about?

NCT02554630 is a clinical study titled "Novel Mechanisms and Approaches to Treat Neonatal Sepsis". 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. ...

What is the current status of trial NCT02554630?

This trial is currently completed. The enrollment target is 142 participants. The study started on 2016-02. Estimated completion is 2022-10-21.

What interventions are being tested in trial NCT02554630?

The interventions under investigation include: Blood Collection (OTHER), Adjuvant (OTHER).

Who is sponsoring clinical trial NCT02554630?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.