2 Clinical Trials for Various Conditions
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.
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study. Study Primary Objective: • To assess improvement in bloating symptoms Study Secondary Objectives: * To assess safety and tolerability of the formulation * To compare the time taken for perceptual improvement in bloating/distention * Enzyme blood assays * To assess quality of life indices