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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 is a Phase 2 study that has completed, run by Intermountain Health Care. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00331201
The ClinicalTrials.gov registry entry for NCT00331201 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAFEstart is the first listed.
NCT00331201 reports 0 study locations.
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.
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