- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00779753
Determination of Lysine Requirement in the Parenterally Fed Neonate
August 1, 2013 updated by: Karen Chapman, The Hospital for Sick Children
The purpose of this study is to establish the parenteral lysine requirements for neonates.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates.
Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins.
In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies.
We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada
- The Hospital for Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically stable neonates on TPN
- minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
- Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
- Weight of ≥ 1.5 kg
- NPO or ≤10% of total protein requirement consumed enterally
Exclusion Criteria:
- Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neonates
Sixteen neonates admitted to the Neonatal Intensive Care Unit (NICU) at the Hospital for Sick Children (SickKids) will be required for this study.
The diagnoses will include, but are not limited to, the following: Trachea-esophageal fistula and/or esophageal atresia, Congenital diaphragmatic hernia, imperforate anus, Hirschsprung's disease, Malrotation with or without volvulus, Intestinal atresias, Gastroschisis, Omphalocele, Necrotizing enterocolitis, Respiratory distress syndrome.
|
The infants will be placed on a standard Primene solution for the first 24 hours of the study to obtain baseline values.
During the second 24 hours they will receive an amino acid solution that has a different amount of lysine currently found in Primene, all lipid, CHO, minerals, vitamins and trace elements will remain unchanged.
The Parenteral lysine will be studied at the following intake levels: 100, 110, 120, 130, 135, 140, 145, 150 , 155, 165, 170, 180, 200, 230, 245, 260mg/kg/d.
The minimum energy intake will be 85-90 kcal/kg/day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment
Time Frame: 2 days
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Breath samples will be collected for the measurement of CO2 enrichment in expired air
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Chapman, RN, PhD (c), The Hospital for Sick Children, Toronto, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chapman KP, Elango R, Ball RO, Pencharz PB. Splanchnic first pass disappearance of threonine and lysine do not differ in healthy men in the fed state. J Nutr. 2013 Mar;143(3):290-4. doi: 10.3945/jn.112.168328. Epub 2013 Jan 16.
- Chapman KP, Courtney-Martin G, Moore AM, Langer JC, Tomlinson C, Ball RO, Pencharz PB. Lysine requirement in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2010 Apr;91(4):958-65. doi: 10.3945/ajcn.2009.28729. Epub 2010 Feb 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
October 23, 2008
First Submitted That Met QC Criteria
October 23, 2008
First Posted (Estimate)
October 24, 2008
Study Record Updates
Last Update Posted (Estimate)
August 5, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0019880597
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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