A phase 1 trial testing an enteral solution patterned after human amniotic fluid to treat feeding intolerance

Feeding intolerance is a common problem in neonates; in some cases it may be related to atrophic changes in the small bowel mucosa. In these infants, feeding tolerance might improve after oral administration of enterocyte growth factors in a sterile, isotonic, noncaloric solution patterned after human amniotic fluid.

Ten infants who met the study criteria for feeding intolerance were enrolled in this pilot trial. The test solution was administered, 2.5 mL/kg every 3 hours, until 80 mL/kg/day of milk feedings were tolerated, or for a maximum of 7 days. When milk feedings were prescribed, they were mixed with the test solution. Volumes of milk feedings were increased in amounts determined by the attending neonatologist and neonatal nurse practitioner. The outcome was the net average enteral kilocalories per kilogram of body weight per day (kcal/kg/day) for 3 periods: (1) the 3 days before the test treatment was begun, (2) the days the test treatment was administered, and (3) the 7 days following cessation of the test treatment.

At study entry the infants' chronological ages ranged from 3 to 65 days. All infants tolerated the test solution, which was given for a mean of 5 days (range 3 to 7 days). During that period, the infants received more enteral calories (mean 18 kcal/kg/day, range 1 to 32) than during the preceding 3 day period (mean 3 kcal/kg/day, range 0 to 7, P < 0.05). During the 7 days following the test treatment the infants received 87 enteral kcal/kg/day (range 11 to 109, P < 0.02 compared to the treatment period).

In this Phase 1 pilot trial, 10 heterogeneous infants in the neonatal intensive care unit with feeding intolerance had a significant increase in milk feedings after treatment with a sterile, isotonic, noncaloric solution patterned after human amniotic fluid.