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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.
ClinicalTrials.gov Identifier: NCT00779753
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Parenteral Lysine Requirements Parenteral Feedings Dietary Supplement: Amino Acid Solution with different amount of Lysine

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Determination of Lysine Requirement in the Parenterally Fed Neonate
Study Start Date : July 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions

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.
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Breath samples will be collected for the measurement of CO2 enrichment in expired air [ Time Frame: 2 days ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779753

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Karen Chapman, RN, PhD (c) The Hospital for Sick Children, Toronto, Canada
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00779753     History of Changes
Other Study ID Numbers: 0019880597
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013

Keywords provided by Karen Chapman, The Hospital for Sick Children:
Parenteral Feeding