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The purpose of this study is to establish the parenteral lysine requirements for neonates.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid Solution with different amount of Lysine | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Breath samples will be collected for the measurement of CO2 enrichment in expired air | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Chapman, RN, PhD (c) | The Hospital for Sick Children, Toronto, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23325919 | Derived | 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. | |
| 20164307 | Derived | 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. |
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| ID | Term |
|---|---|
| C545824 | amino-acid, glucose, and electrolyte solution |
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