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

Premature Birth Clinical Trial

— TPNAC  

Official title:

Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062724
• Other study ID #: 2009-785-080
• Status: Terminated
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: June 8, 2017
• Start date: May 2011
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: July 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Premature Birth

Intervention

Other:
• Primene 10 % from Baxter
Primene solution will be calculated in g/kg/day and administered in ml/day Active Comparator: Trophamine This group of neonates will be receive the Trophamine amino acid solution from Pisa laboratories and the other arm will be receive a Primene amino acid solution (10 %) from Baxter laboratories. For infants identified, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat and daily enteral intake (ml/kg/d) of breast milk or formula will be record.

Locations

Country	Name	City	State
Mexico	Intensive Care Unit and Nutrition Parenteral Department, Pediatric Hospital , Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Amino Acid levels and Frequency of Cholestasis in Neonates		At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN