Parenteral Feedings, Parenteral Lysine Requirements
Conditions
Keywords
Parenteral Feeding, Neonate, Lysine
Brief summary
The purpose of this study is to establish the parenteral lysine requirements for neonates.
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.
Interventions
DIETARY_SUPPLEMENTAmino Acid Solution with different amount of Lysine
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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Breath samples will be collected for the measurement of CO2 enrichment in expired air | 2 days |
Countries
Canada
Outcome results
None listed