Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates

NCT ID: NCT01062724


Title
Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
Purpose
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.
Details
Total parenteral nutrition is an essential component of the care of premature and ill infants. Prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. The most common of these is total parenteral nutrition-associated cholestasis (TPNAC), that occurs because of reduced bile flow from the liver into the duodenum. Cholestasis causes liver damage and in some cases, death. Infant and neonate are at particular risk for this complication. The incidence of TPNAC ranges from 7.4 to 84%. Animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. An appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. Therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during Primene and Trophamine use.
Conditions
Premature Birth
Keywords
Cholestasis, TPN, Neonates, Primene, Trophamine, Methionine, Cysteine, Taurine, Total Parenteral Nutrition
Source
Coordinación de Investigación en Salud, Mexico
Sponsors
Coordinación de Investigación en Salud, Mexico, Instituto Mexicano del Seguro Social
Status
Active, not recruiting
Acronym
TPNAC
Last Updated
07 Feb 2016
URL
Official Link
Locations
Mexico