SAFEstart Feeding Intolerance Study Phase II

Completed · Phase 2

Conditions studied: Feeding Intolerance, Abdominal Distention, Gastric Residual, Emesis and Diarrhea, Blood in Stool

In brief

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.

Key facts

Study ID

NCT00331201

Run by

Intermountain Health Care, Inc.

People needed

20

Starts

2005-07-01

Expected to finish

2006-04-01

Last updated by the study team

2006-11-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• McKay-Dee Hospital Center — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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