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.