SAFEstart Feeding Intolerance Study Phase II
SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 25, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedNovember 28, 2006
November 1, 2006
May 25, 2006
November 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure will be the number of calories/kg taken enterally during the seven days after the four days of SAFEstart (or sham) treatment
Interventions
Eligibility Criteria
You may qualify if:
- Have feeding intolerance (defined in the following section).
- Be expected (by declaration of the Attending Neonatologist) to survive at least 28 days.
- Have documented informed consent for participation in the study.
You may not qualify if:
- Have a congenital surgical condition involving the intestine, such as tracheoesophageal fistulae, diaphragmatic hernia, Hirschprung's disease, bowel atresia, gastroschisis, or omphalocele.
- Be so ill as to require mechanical ventilation with \>50% FIO2 at the time of study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy K Barney, NNP
Intermountain Health Care, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2006
First Posted
May 29, 2006
Study Start
July 1, 2005
Study Completion
April 1, 2006
Last Updated
November 28, 2006
Record last verified: 2006-11