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

Coordinación de Investigación en Salud, Mexico

Status and phase: Terminated; Phase 3

Conditions: Premature Birth

Treatments: Other: Primene 10 % from Baxter

Study type: Interventional

Funder types: Other

Identifiers

NCT01062724

2009-785-080

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 94 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 explained

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups

Trophamine

No Intervention group

Description:

This group of neonates will be receive the Trophamine amino acids solution from Pisa laboratories as an active comparator with Primene. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition.

Primene 10% from Baxter

Experimental group

Description:

This group of neonates will be receive the Primene amino acids solution (10 %) from Baxter laboratories as other active comparator with Trophamine. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition.

Treatment:

Other: Primene 10 % from Baxter