Feeding Intolerance Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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