Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01776268 · ClinicalTrials.gov registry record · NA
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT01776268 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 99 participants.
The verdict
NCT01776268, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors. An immature immune system underlies the frequency and severity of infections in this vulnerable population. The mouth is the site where microbes first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva kill microbes and improve immune cell function. Low APP levels increase the risk of developing infection. Colostrum and human milk reduce the risk of infection. This protective effect of human milk may come from supplying or stimulating infant production of APPs. No prior investigation has determined the concentration of APPs in saliva or the effect of human milk/formula on the APP concentrations in saliva. Objective(s) and Hypothesis(es): The investigators objectives are to identify and serially determine the concentrations of key APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and specific mass spectroscopy methods. The investigators study is designed to test the hypotheses that (a) all saliva APPs increase over time, (b) APP concentrations are higher in colostrum as compared to human milk, and (c) APPs are increased in saliva of infants that receive colostrum orally compared to those that do not. Potential Impact: If increased saliva APP levels are associated with oral colostrum priming, this discovery would advance understanding of the immune properties of human milk and identify oral APPs as important immune elements and potential therapeutic targets in this vulnerable population. This knowledge has the potential to alter feeding practices and provide a safe, low cost means to improve immune function and significantly improve outcomes for preterm infants.
Interventions
- OTHER Oral priming
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01776268
The ClinicalTrials.gov registry entry for NCT01776268 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral priming is the first listed.
NCT01776268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01776268 about?
NCT01776268 is a clinical study titled "Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants". Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors. An immature immune system underlies the frequency and severity of infections in this vulnerable population. The mouth is the site where microbes first meet the m...
What is the current status of trial NCT01776268?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2013-02. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01776268?
The interventions under investigation include: Oral priming (OTHER).
Who is sponsoring clinical trial NCT01776268?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.