Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01443091 · ClinicalTrials.gov registry record · NA
Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT01443091 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 43 participants.
The verdict
NCT01443091, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.
Interventions
- OTHER application of mother's own colostrum
- OTHER application of sterile water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01443091
The ClinicalTrials.gov registry entry for NCT01443091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which application of mother's own colostrum is the first listed.
NCT01443091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01443091 about?
NCT01443091 is a clinical study titled "Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants". Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral fee...
What is the current status of trial NCT01443091?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01443091?
The interventions under investigation include: application of mother's own colostrum (OTHER), application of sterile water (OTHER).
Who is sponsoring clinical trial NCT01443091?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 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.