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NCT00331201 · ClinicalTrials.gov registry record · Phase 2
SAFEstart Feeding Intolerance Study Phase II
A Phase 2 study, sponsored by Intermountain Health Care.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00331201: Completed Phase 2 study, sponsored by Intermountain Health Care.
NCT00331201 is a Phase 2 study that has completed, run by Intermountain Health Care. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00331201, a Phase 2 study, has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We developed a method aimed at treating intestinal villous atrophy. We accomplished preclinical testing of the product, and four Phase I clinical trials, including two at McKay-Dee Hospital in 2004. Our preparation is a sterile, isotonic, solution that simulates human amniotic fluid in electrolyte composition, albumin concentration, and two enterocyte growth factors that are present in human amniotic fluid; erythropoietin and granulocyte colony-stimulating factor. We termed the product SAFEstart, using the acronym Simulated Amniotic Fluid for Enteral administration. This trial on the efficacy and safety of SAFEstart administration as a treatment for neonates who have feeding intolerance. Hypothesis is that infants with feeding intolerance, randomized to the SAFEstart will have a greater enteral calories per kilogram per day for the seven days following conclusion of the SAFEstart administration.
Interventions
- DRUG SAFEstart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-07 |
| Est. Completion | 2006-04 |
| Phase | Phase 2 |
What the finished NCT00331201 record still lists
NCT00331201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which SAFEstart is the first listed.
NCT00331201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00331201 about?
NCT00331201 is a clinical study titled "SAFEstart Feeding Intolerance Study Phase II". Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We developed a method aimed at treating intestinal villous atrophy. We accomplished preclinical testing of the product, a...
What is the current status of trial NCT00331201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2005-07. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00331201?
The interventions under investigation include: SAFEstart (DRUG).
Who is sponsoring clinical trial NCT00331201?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00331201's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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