Determination of Lysine Requirement in the Parenterally Fed Neonate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779753
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):
Karen Chapman, The Hospital for Sick Children

October 23, 2008
October 24, 2008
August 5, 2013
July 2008
June 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00779753 on Archive Site
Breath samples will be collected for the measurement of CO2 enrichment in expired air [ Time Frame: 2 days ]
Same as current
Not Provided
Not Provided
Determination of Lysine Requirement in the Parenterally Fed Neonate
Determination of Lysine Requirement in the Parenterally Fed Neonate
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.
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Parenteral Lysine Requirements
  • Parenteral Feedings
Dietary Supplement: Amino 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.
Other Names:
  • Trophamine
  • Primene
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.
Intervention: Dietary Supplement: Amino Acid Solution with different amount of Lysine

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (Final data collection date for primary outcome measure)

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: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Karen Chapman, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Karen Chapman, RN, PhD (c) The Hospital for Sick Children, Toronto, Canada
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP