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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: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT01443091 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01443091 record still lists
NCT01443091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which application of mother's own colostrum is the first listed.
NCT01443091 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01443091's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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