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

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ClinicalTrials.gov Identifier: NCT01062724
Recruitment Status : Terminated
First Posted : February 4, 2010
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Premature Birth Other: Primene 10 % from Baxter Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
Actual Study Start Date : May 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Trophamine
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: Primene 10% from Baxter
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.
 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.
Other Name: PRIMENE 10%, code IMSS 2512 01 01


Outcome Measures
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Primary Outcome Measures :
  1. 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
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062724


Locations
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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
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Principal Investigator: Maria de Lourdes Barbosa-Cortés, MSc Instituto Mexicano del Seguro Social
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: María de Lourdes Barbosa Cortés, Associated Researcher, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01062724    
Other Study ID Numbers: 2009-785-080
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico:
Cholestasis
TPN
Neonates
Primene
Trophamine
 Methionine
Cysteine
Taurine
Total Parenteral Nutrition
Additional relevant MeSH terms:
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Cholestasis
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases