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

NCT01062724 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-06-09

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Maria de Lourdes Barbosa-Cortés, MSc · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-11-30
Completion
2016-07-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062724 on ClinicalTrials.gov