Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
Information source: Coordinación de Investigación en Salud, Mexico
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Birth
Intervention: Primene and Trophamine are added in TPN (Other)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: Coordinación de Investigación en Salud, Mexico
Official(s) and/or principal investigator(s):
Maria de Lourdes Barbosa-CortÃ©s, MSc, Principal Investigator, Affiliation: Instituto Mexicano del Seguro Social
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.
Official title: Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Blood Amino Acid levels and Frequency of Cholestasis in Neonates
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.
Minimum age: N/A.
Maximum age: 28 Days.
- Newborns greater than 1500 g who enter the Intensive Care Unit and their pathology
requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal
atresia, short bowel syndrome).
- Gestational age greater than 30 weeks
- Patients with normal liver function tests for their age, prior to the initiation of
total parenteral nutrition.
- Authorization from both parents or legal guardian for recruiting of the child into
the study with consent signed form after the purpose and procedures have been
- Patients with acute renal failure
- Congenital liver disease, end-stage liver disease
- Patients with liver damage secondary to viral or bacterial infection
- Patients with liver damage secondary to drugs
Locations and Contacts
Intensive Care Unit and Nutrition Parenteral Department, Pediatric Hospital , Instituto Mexicano del Seguro Social, Mexico, Distrito Federal 06720, Mexico
Starting date: February 2011
Last updated: March 11, 2015