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NCT02116699 · ClinicalTrials.gov registry record · NA
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
A NA study, sponsored by Endeavor Health.
- Completed
- Registry status
- NA
- Development phase
- 260
- Enrollment target
NCT02116699: Completed NA study, sponsored by Endeavor Health.
NCT02116699 is a NA study that has completed, run by Endeavor Health. The registered enrollment target is 260 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02116699, a NA study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 260 participants
- Enrollment target
Study Summary
Extremely premature (BW\<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.
Primary Outcome
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
Interventions
- OTHER oropharyngeal mother's milk
- OTHER oropharyngeal sterile water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2013-11-20 |
| Est. Completion | 2022-01-04 |
| Phase | NA |
What the finished NCT02116699 record still lists
NCT02116699 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which oropharyngeal mother's milk is the first listed.
NCT02116699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02116699 about?
NCT02116699 is a clinical study titled "Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)". Extremely premature (BW\<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature inf...
What is the current status of trial NCT02116699?
This trial is currently completed. It is a NA study. The enrollment target is 260 participants. The study started on 2013-11-20. Estimated completion is 2022-01-04.
What interventions are being tested in trial NCT02116699?
The interventions under investigation include: oropharyngeal mother's milk (OTHER), oropharyngeal sterile water (OTHER).
Who is sponsoring clinical trial NCT02116699?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02116699's enrollment target sits among peer trials
260 397th of 2000 higher than 1,601 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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