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SAFEstart

Development stage: Phase 2
Lead developer: Intermountain Health
Modality: Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration: Oral

Overview

SAFEstart is an investigational enteral, sterile isotonic simulated amniotic-fluid solution developed by Intermountain Health for neonatal feeding intolerance in the neonatal intensive care unit. The formulation was designed to approximate human amniotic fluid in electrolyte composition and albumin concentration and includes the enterocyte trophic factors erythropoietin and granulocyte colony-stimulating factor. It is intended to support intestinal villous growth and maturation, improve feeding tolerance, and increase enteral caloric intake in affected neonates. SAFEstart was evaluated in a completed Phase II randomized controlled trial for feeding intolerance.

Other names: Simulated Amniotic Fluid for Enteral administrationsimulated amniotic fluid

Targets

CSF3R (Granulocyte colony-stimulating factor receptor)Erythropoietin Receptor

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