Determination of Lysine Requirement in the Parenterally Fed Neonate - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00779753

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

Drug Information available for: Amino acids, branched-chain Lysine Lysine acetate Lysine hydrochloride Lipids BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Determination of Lysine Requirement in the Parenterally Fed Neonate

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 ]

Estimated Enrollment:	16
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Neonates: Experimental 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.

Arms

Assigned Interventions

Neonates: Experimental

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.

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

Contacts

Contact: Karen Chapman, RN, PhD (c)

416-813-6121

karen.chapman@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada
Contact: Karen Chapman, RN, PhD (c) 416-813-6121 karen.chapman@sickkids.ca
Principal Investigator: Karen Chapman, RN, PhD (c)
Sub-Investigator: Glenda Couryney-Martin, RD, PhD (c)
Sub-Investigator: Aideen Moore, MD
Sub-Investigator: Jack Langer, MD
Sub-Investigator: Paul Pencharz, MD, PhD

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

Responsible Party:	The Hospital for Sick Children, Toronto, Canada ( Karen Chapman )
Study ID Numbers:	0019880597
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779753
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Parenteral Feeding
Neonate
Lysine

ClinicalTrials.gov processed this record on January 14, 2009