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Determination of Lysine Requirement in the Parenterally Fed Neonate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00779753
First received: October 23, 2008
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to establish the parenteral lysine requirements for neonates.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Determination of Lysine Requirement in the Parenterally Fed Neonate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breath samples will be collected for the measurement of CO2 enrichment in expired air [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779753

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

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00779753     History of Changes
Other Study ID Numbers: 0019880597
Study First Received: October 23, 2008
Last Updated: June 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Parenteral Feeding
Neonate
Lysine

ClinicalTrials.gov processed this record on June 18, 2013