SAFEstart Feeding Intolerance Study Phase II

This study has been completed.
Sponsor:
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00331201
First received: May 25, 2006
Last updated: November 27, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Feeding Intolerance
Abdominal Distention
Gastric Residual
Emesis and Diarrhea
Blood in Stool
Drug: SAFEstart
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: July 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331201

Locations
United States, Utah
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Cindy K Barney, NNP Intermountain Health Care, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00331201     History of Changes
Other Study ID Numbers: 402
Study First Received: May 25, 2006
Last Updated: November 27, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Intermountain Health Care, Inc.:
NEC

ClinicalTrials.gov processed this record on September 18, 2014