Determination of Lysine Requirement in the Parenterally Fed Neonate

Study Overview
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Brief Summary
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The purpose of this study is to establish the parenteral lysine requirements for neonates.

Detailed Description
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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.

Official Title
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Determination of Lysine Requirement in the Parenterally Fed Neonate

Conditions
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Parenteral Lysine Requirements, Parenteral Feedings

Intervention / Treatment
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* Dietary Supplement: Amino Acid Solution with different amount of Lysine


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neonates<br>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. | Dietary Supplement: Amino Acid Solution with different amount of Lysine<br>* 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.<br>* Other names: Primene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath samples will be collected for the measurement of CO2 enrichment in expired air |  | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral Feeding, Neonate, Lysine