Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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29 June 2015 |
Main ID: |
NCT02478086 |
Date of registration:
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31/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of High vs. Standard Protein Intake in Newborn Extreme Premature
experimental |
Scientific title:
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Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature |
Date of first enrolment:
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August 2012 |
Target sample size:
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52 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02478086 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Victor Godinez, Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g
Exclusion Criteria:
1. Preterm infant with severe congenital malformations.
2. Patients with acute kidney failure.
3. Inform consent form not signed.
Age minimum:
N/A
Age maximum:
4 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malnutrition
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Abnormal Renal Function
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Intervention(s)
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Dietary Supplement: use amine acids parenteral 3.5g
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Dietary Supplement: use amine acids parenteral 4g
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Primary Outcome(s)
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Renal function: urea, creatinina and urea nitrogen
[Time Frame: at 48h - 28 days]
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Secondary ID(s)
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R-2012-1002-63
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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