Determination of Lysine Requirement in the Parenterally Fed Neonate

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00779753

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parenteral Lysine Requirements Parenteral Feedings	Dietary Supplement: Amino Acid Solution with different amount of Lysine	N/A

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

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 :

Jul 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

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

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

Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment [2 days]

Secondary Outcome Measures

Breath samples will be collected for the measurement of CO2 enrichment in expired air [2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT00779753

Other Study ID Numbers:

0019880597

First Posted:

Oct 24, 2008

Last Update Posted:

Aug 5, 2013

Last Verified:

Aug 1, 2013

Keywords provided by Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children

Parenteral Feeding

Neonate

Lysine

Additional relevant MeSH terms:

Amino-acid, glucose, and electrolyte solution

Study Results

No Results Posted as of Aug 5, 2013