Tolerance of an enterally administered simulated amniotic fluid-like solution by neonates recovering from surgery for congenital bowel abnormalities
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Objective: We report a single-centered, Phase I pilot trial, testing the enteral administration of an experimental amniotic fluid-like solution to 10 neonates who were otherwise NPOfollowin surgery for congenital bowel abnormalities. The overall hypothesis was that the trophic effect of the solution on intestinal villi would facilitate advancement to full enteral feedings. The specific hypothesis tested in this pilot trial was that the solution would be tolerated. Study Design: Ten neonates who were NPO following surgery for congenital bowel abnormalities, were studied before any trophic feedings were begun. Each received an experimental, sterile, isotonic, amniotic fluid-like solution at a dose of 20 ml/kd/day enterally. When milk feedings were begun they were mixed with the experimental solution. Increases in the volume of milk feedings occured at the discretion of the neonatologist and surgeon, and the experimental solution was discontinued any time the neonatologist or surgeon felt it was not tolerated, or when 100 ml of milk feedings/kg/day was achieved. We quantified the amount and character of emesis, stools, and gastric residuals, measured abdominal girth and blood pressure, looked for skin rashes, and sought any signs of intolerance or adverse events. We recorded the days to achieve milk feedings of 20, 50, 100 and 120 ml/kg/day and length of hospital stay. Results: The experimental solution was begun 4 to 32 days after surgery, invariability prior to the institution of trophic milk feedings. All subjects completed the doses with no evidence of intolerance. All achieved 100 ml/kg of milk feeding 14 days, or fewer, following institution of the experimental solutions (mean 11.1 days, range, 3 to 14). All lived and were discharged home 20.2 days (range, 8 to 42) after the experimental solution was begun. Conclusions: In this plot trial involving 10 neonates who had surgery for congenital bowel abnormalities, the enteral administration of a sterile, isotonic, amniotic fluid-like solutions was tolerated. © 2004 Nature Publishing Group All rights reserved.
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isotonic solution; recombinant erythropoietin; recombinant granulocyte colony stimulating factor; serum albumin; amnion fluid; article; blood pressure measurement; clinical article; clinical trial; controlled clinical trial; controlled study; diarrhea; drug tolerability; enteric feeding; feces analysis; hospital discharge; hospitalization; human; hypertension; hypotension; hypothesis; infant feeding; intestine malformation; intestine villus; medical decision making; newborn; newborn surgery; pediatrician; phase 1 clinical trial; pilot study; postoperative care; rash; stomach content; surgeon; vomiting; Drug Combinations; Enteral Nutrition; Epoetin Alfa; Esophageal Atresia; Filgrastim; Gastroschisis; Hematinics; Hernia, Umbilical; Humans; Infant, Newborn; Intestines; Pilot Projects
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