Overview

This trial is active, not recruiting.

Condition premature birth
Treatment primene 10 % from baxter
Phase phase 3
Sponsor Coordinación de Investigación en Salud, Mexico
Collaborator Instituto Mexicano del Seguro Social
Start date February 2011
End date January 2016
Trial size 110 participants
Trial identifier NCT01062724, 2009-785-080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
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.
(Experimental)
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.
primene 10 % from baxter PRIMENE 10%, code IMSS 2512 01 01
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.

Primary Outcomes

Measure
Blood Amino Acid levels and Frequency of Cholestasis in Neonates
time frame: At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN

Eligibility Criteria

Male or female participants up to 28 days old.

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

Additional Information

Official title Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
Principal investigator Maria de Lourdes Barbosa-Cortés, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico.