Feeding IntolerancePhase 2NCT00331201
SAFEstart Feeding Intolerance Study Phase II
A Phase 2 study testing SAFEstart in people with Feeding Intolerance and Abdominal Distention, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding Intolerance, Abdominal Distention, Gastric Residual
- What is being tested?
- SAFEstart
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial
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.
Read the detailed description
Feeding intolerance is relatively common in the NICU. It can manifest as emesis, diarrhea, increased abdominal girth (bloating), or in the most severe cases as necrotizing enterocolitis. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. Feeding intolerance likely has many causes. One cause that may be particularly common in the NICU is atrophy of the intestinal mucosa, which occurs during enteral fasting (when a patient is NPO). Significant intestinal villous atrophy occurs after being NPO for even 1-2 days; even if parenteral nutrition is adequate.
We developed a method aimed at preventing intestinal villous atrophy of neonates who are NPO. We accomplished preclinical testing of the product, and we completed two Phase I clinical trials involving 60 neonates. 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.
SAFEstart has been tested in neonates who have never been fed, as a means of preventing villous mucosal atrophy. However, it has not yet been tested in neonates who develop feeding intolerance after several days or weeks of life. When feeding intolerance develops in such patients, the current treatments include changing formulas, continuous feeding, but does not include using SAFEstart.
It is possible that SAFEstart administration, 2.5 mL/kg enterally every three hours as we have previously done with preterm neonates beginning on the first day of life, would provide benefit to these older neonates with acquired feeding intolerance. If such infants have mucosal atrophy as part of their feeding problem, the growth factors in SAFEstart might indeed result in improved feeding tolerance.
We propose a Phase II exploratory trial among 20 neonates in the McKay-Dee NICU who develop the problem of feeding intolerance. Specifically, we propose that when feeding intolerance is diagnosed, 20 mL/kg/day of SAFEstart will be administered (every three hour gavage or nipple feedings) and that this will be continued for a period of up to one week, in an attempt to resolve the feeding intolerance.
- Conditions
- Feeding Intolerance, Abdominal Distention, Gastric Residual, Emesis and Diarrhea, Blood in Stool
- Being tested
- SAFEstart
- Keywords
- NEC
- Medical subject headings
- Vomiting, Diarrhea, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFEstartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startJul 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Cindy K Barney, NNP, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331201
- Sponsor's protocol ID
- 402
- Status last verified
- Nov 2006
- First submitted
- 25 May 2006
- Last updated
- 28 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00331201
- Acronym / sponsor ID
- 402
- Conditions
- Feeding Intolerance, Abdominal Distention, Gastric Residual, Emesis and Diarrhea, Blood in Stool
- Keywords
- NEC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Jul 2005
- Study completion
- Apr 2006
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Feeding intolerance is relatively common in the NICU. It can manifest as emesis, diarrhea, increased abdominal girth (bloating), or in the most severe cases as necrotizing enterocolitis. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. Feeding intolerance likely has many causes. One cause that may be particularly common in the NICU is atrophy of the intestinal mucosa, which occurs during enteral fasting (when a patient is NPO). Significant intestinal villous atrophy occurs after being NPO for even 1-2 days; even if parenteral nutrition is adequate.
We developed a method aimed at preventing intestinal villous atrophy of neonates who are NPO. We accomplished preclinical testing of the product, and we completed two Phase I clinical trials involving 60 neonates. 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.
SAFEstart has been tested in neonates who have never been fed, as a means of preventing villous mucosal atrophy. However, it has not yet been tested in neonates who develop feeding intolerance after several days or weeks of life. When feeding intolerance develops in such patients, the current treatments include changing formulas, continuous feeding, but does not include using SAFEstart.
It is possible that SAFEstart administration, 2.5 mL/kg enterally every three hours as we have previously done with preterm neonates beginning on the first day of life, would provide benefit to these older neonates with acquired feeding intolerance. If such infants have mucosal atrophy as part of their feeding problem, the growth factors in SAFEstart might indeed result in improved feeding tolerance.
We propose a Phase II exploratory trial among 20 neonates in the McKay-Dee NICU who develop the problem of feeding intolerance. Specifically, we propose that when feeding intolerance is diagnosed, 20 mL/kg/day of SAFEstart will be administered (every three hour gavage or nipple feedings) and that this will be continued for a period of up to one week, in an attempt to resolve the feeding intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFEstart | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2006.
Related trials for Feeding Intolerance
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Enteral Feeding Intolerance
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Multi Organ Failure, Exocrine Pancreatic Insufficiency
Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
Not yet recruiting
Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
Enteral Feeding Intolerance, ICU
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy K Barney, NNP principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAFEstart in people with Feeding Intolerance and Abdominal Distention, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2006.