title: Tolerance of an enterally administered simulated amniotic fluid-like solution by neonates recovering from surgery for congenital bowel abnormalities.
abstract: 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 "NPO" following 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.
  
  
  METHODS
  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/kg/day enterally. When milk feedings were begun they were mixed with the experimental solution. Increases in the volume of milk feedings occurred 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, invariably 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 feedings 14 days, or fewer, following institution of the experimental solution (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 pilot trial involving 10 neonates who had surgery for congenital bowel abnormalities, the enteral administration of a sterile, isotonic, amniotic fluid-like solution was tolerated.
authors.affiliation: Division of Neonatology. Hospital General Dr. Ignacio Morones Prieto, Univesidad Autónoma de San Luis Potosi City, San Luis Potosi, Mexico.
authors.forename: Victoria
authors.initials: V
authors.lastname: Lima-Rogel
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Ojeda
authors.forename: Carolina
authors.initials: C
authors.lastname: Villegas
authors.forename: Abraham
authors.initials: A
authors.lastname: Torres-Montes
authors.forename: Silvano
authors.initials: S
authors.lastname: Medrano
authors.forename: Darlene A
authors.initials: DA
authors.lastname: Calhoun
authors.forename: Robert D
authors.initials: RD
authors.lastname: Christensen
mesh_terms: D004338:Drug Combinations; D004750:Enteral Nutrition / Q000379:methods*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D004933:Esophageal Atresia / Q000601:surgery*; D000069585:Filgrastim; D020139:Gastroschisis / Q000601:surgery*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage*; D006554:Hernia, Umbilical / Q000601:surgery*; D006801:Humans; D007231:Infant, Newborn; D007422:Intestines / Q000002:abnormalities / Q000601:surgery; D010865:Pilot Projects; D011994:Recombinant Proteins
chemical_list: D004338:Drug Combinations; D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000068817:Epoetin Alfa; D000069585:Filgrastim