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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01062724
First received: February 3, 2010
Last updated: August 5, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Premature Birth
Other: Primene and Trophamine are added in TPN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Primene and Trophamine are added in TPN
These solutions 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.
Other Names:
  • PRIMENE 10%, code IMSS 2512 01 01
  • TROPHAMINE 10% code IMSS 5393 01 01
Active Comparator: Primene
This group will be receive Primene amino acid solution
Other: Primene and Trophamine are added in TPN
These solutions 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.
Other Names:
  • PRIMENE 10%, code IMSS 2512 01 01
  • TROPHAMINE 10% code IMSS 5393 01 01

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062724

Locations
Mexico
Intensive Care Unit and Nutrition Parenteral Department, Pediatric Hospital , Instituto Mexicano del Seguro Social
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Maria de Lourdes Barbosa-Cortés, MSc Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: María de Lourdes Barbosa Cortés, Associated Researcher, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01062724     History of Changes
Other Study ID Numbers: 2009-785-080
Study First Received: February 3, 2010
Last Updated: August 5, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Cholestasis
TPN
Neonates
Primene
Trophamine
Methionine
Cysteine
Taurine
Total Parenteral Nutrition

Additional relevant MeSH terms:
Cholestasis
Premature Birth
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Amino-acid, glucose, and electrolyte solution
Pharmaceutical Solutions
Parenteral Nutrition Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014