NCT01062724

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 9, 2017

Status Verified

February 1, 2016

Enrollment Period

4.5 years

First QC Date

February 3, 2010

Last Update Submit

June 8, 2017

Conditions

Premature Birth

Keywords

CholestasisTPNNeonatesPrimeneTrophamineMethionineCysteineTaurineTotal Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Trophamine

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.

Primene 10% from Baxter

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.

Other: Primene 10 % from Baxter

Interventions

Primene 10 % from BaxterOTHER

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.

Also known as: PRIMENE 10%, code IMSS 2512 01 01
Primene 10% from Baxter

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit and Nutrition Parenteral Department, Pediatric Hospital , Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Premature BirthCholestasisHyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria de Lourdes Barbosa-Cortés, MSc

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Researcher

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

May 1, 2011

Primary Completion

November 1, 2015

Study Completion

July 1, 2016

Last Updated

June 9, 2017

Record last verified: 2016-02

Locations

ME(1)